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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.

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ClinicalTrials.gov Identifier: NCT00545233
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : May 7, 2012
Last Update Posted : May 7, 2012
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]
Drug: Pioglitazone
Enrollment 155
Recruitment Details  
Pre-assignment Details Patients randomized to the pioglitazone arm participated in a 16-week pioglitazone run-in (Week -16 to Week 0) prior to beginning anti-HCV therapy: PEG-INF alpha-2a [Pegasys] plus ribavarin [Copegus]. Patients randomized to the without pioglitazone arm started anti-HCV therapy immediately.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period. Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Period Title: Overall Study
Started 79 76
Safety Set 77 75
Intent-to-Treat (ITT) 77 73
Completed 33 41
Not Completed 46 35
Reason Not Completed
Adverse Event             10             5
Violation of Selection Criteria at Entry             5             1
Protocol Violation             2             0
Refused Treatment             9             7
Failure to Return             4             6
Insufficient response             14             15
Physician Decision             2             1
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin Total
Hide Arm/Group Description Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period. Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period. Total of all reporting groups
Overall Number of Baseline Participants 77 73 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 150 participants
<=40 years 6 8 14
>40 years 71 65 136
[1]
Measure Description: Baseline Measures are based on the Intent-to-Treat Population that includes all participants who received at least one dose of study drug.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 73 participants 150 participants
Female
27
  35.1%
28
  38.4%
55
  36.7%
Male
50
  64.9%
45
  61.6%
95
  63.3%
1.Primary Outcome
Title Change From Initiation of Pegasys Plus Copegus in log10 Hepatitis C Virus Ribonucleic Acid (HCV RNA) Viral Load to Week 12 of Anti-HCV Therapy
Hide Description Serum samples were collected for HCV RNA. The change from initiation of Pegasys plus Copegus to Week 12 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Time Frame Initiation of Pegasys plus Copegus, Week 12 of anti-HCV treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: IU/mL
-3.5  (0.22) -3.7  (0.19)
2.Secondary Outcome
Title Change From Initiation of Pegasys Plus Copegus in log10 HCV RNA Viral Load to Week 24 and Week 48 of Anti-HCV Therapy
Hide Description Serum samples were collected for HCV RNA. The change from Initiation of Pegasys Plus Copegus to Week 24 and Week 48 in HCV RNA titers were calculated. Randomization for the with Pioglitazone arm occurred prior to the 16 week run-in period and randomization for the without Pioglitazone arm occurred prior to the start of anti-HCV treatment.
Time Frame Initiation of Pegasys Plus Copegus, Week 24 and Week 48 of anti-HCV therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Last Observation Carried Forward (LOCF) was used to replace missing data after dropout with the last observed data.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: IU/mL
Week 24 (N=60, 72) -4.0  (0.23) -3.9  (0.21)
Week 48 (N=62, 73) -3.5  (0.27) -3.6  (0.24)
3.Secondary Outcome
Title Percentage of Participants Achieving Virologic Response
Hide Description Virologic response was defined as undetectable HCV RNA < 28 IU/mL. Patients with missing HCV RNA values are considered as non-responders.
Time Frame Weeks 4, 12, 24, 48, 60, 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Measure Type: Number
Unit of Measure: Percentage of Participants
Weeks 4 6.5 16.4
Week 12 33.8 49.3
Week 24 46.8 63.0
Week 48 39.0 56.2
Week 60 26.0 39.7
Week 72 26.0 38.4
4.Secondary Outcome
Title Percentage of Participants With a ≥ 2 log10 Decrease in HCV RNA From Initiation of Pegasys Plus Copegus to Weeks 4, 12, 24, 48, 60, 72
Hide Description Serum samples were collected for HCV RNA. The percentage of participants with a ≥ 2 log10 decrease in HCV RNA from initiation of Pegasys plus Copegus to time point was calculated.
Time Frame Initiation of Pegasys plus Copegus, Weeks 4, 12, 24, 48, 60, 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population included all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Measure Type: Number
Unit of Measure: Percentage of Participants
Weeks 4 41.6 52.1
Week 12 58.4 76.7
Week 24 51.9 72.6
Week 48 39.0 54.8
Week 60 26.0 41.1
Week 72 26.0 37.0
5.Secondary Outcome
Title Percentage of Participants With a Virological Relapse at Week 72 (24 Weeks After the End of Anti-HCV Treatment)
Hide Description Virologic relapse was defined as the reappearance of HCV-RNA in serum after PEG-INF alpha 2a therapy is discontinued in a patient who was HCV-RNA undetectable at the completion of anti-HCV therapy.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Measure Type: Number
Unit of Measure: Percentage of Participants
15.6 19.2
6.Secondary Outcome
Title Percentage of Participants With a Confirmed Virological Breakthrough up to 48 Weeks
Hide Description Virological breakthrough is a detectable HCV RNA at any time during anti-HCV treatment up to Week 48 after the attainment of undetectable HCV RNA.
Time Frame Up to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Measure Type: Number
Unit of Measure: Percentage of Participants
15.6 13.7
7.Secondary Outcome
Title Percentage of Nonresponders During the 48 Week Anti-HCV Treatment Period
Hide Description Nonresponders are defined as patients who did not achieve undetectable HCV RNA during anti-HCV treatment
Time Frame Up to 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Measure Type: Number
Unit of Measure: Percentage of Participants
45.5 30.1
8.Secondary Outcome
Title Change in Log10 HCV RNA Viral Load at Assessments From Randomization to 16 Weeks of Pioglitazone Pretreatment Run-In Period for the Pioglitazone Arm Only
Hide Description Serum HCV RNA was collected at randomization and during the pioglitazone run-in period at various time points for the with pioglitazone arm only. The change from randomization to each of these time points was calculated.
Time Frame Randomization (Week-16),Weeks -12, -8, -4 and 0
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population includes all randomized patients who received at least one dose of study drug and had at least one post-randomization HCV RNA assessment. Patients with missing HCV RNA values are considered as non-responders.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of piogliatzone per day orally in the 24 week follow-up period.
Overall Number of Participants Analyzed 77
Mean (Standard Error)
Unit of Measure: IU/mL
Week -12 (n=74) -0.01  (0.037)
Week -8 (n=68) 0.00  (0.049)
Week -4 (n=66) 0.07  (0.048)
Week 0 (n=64) -0.03  (0.046)
9.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose Levels at Each Time Point Assessed
Hide Description

Blood was collected for plasma fasting glucose levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: mmol/L
Week 4 (n=58, 70) -0.4  (0.24) -0.2  (0.17)
Week 8 (n=57, 68) -0.7  (0.25) -0.1  (0.33)
Week 12 (n=55, 66) -0.8  (0.25) -0.6  (0.28)
Week 16 (n=53, 61) -0.8  (0.26) -0.5  (0.36)
Week 20 (n=46, 57) -0.6  (0.19) -0.3  (0.19)
Week 24 (n=47, 61) -0.5  (0.30) -0.3  (0.15)
Week 28 (n=51, 62) -0.4  (0.16) -0.3  (0.16)
Week 32 (n=39, 47) -0.5  (0.19) -0.5  (0.23)
Week 36 (n=38, 46) -0.6  (0.20) -0.4  (0.23)
Week 40 (n=44, 50) -0.4  (0.20) -0.7  (0.20)
Week 44 (n=37, 43) -0.4  (0.33) -0.2  (0.25)
Week 48 (n=34, 46) -0.5  (0.22) -0.1  (0.24)
Week 60 (n=33, 41) -0.6  (0.23) -0.1  (0.34)
Week 72 (n=30, 38) -0.6  (0.22) -0.1  (0.31)
10.Secondary Outcome
Title Change From Baseline in Fasting Insulin Levels at Each Time Point Assessed.
Hide Description

Blood was collected for fasting insulin levels at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: pmol/L
Week 4 (N=56, 43) 6.4  (20.9) -28.4  (30.1)
Week 8 (N=4, 27) -40.6  (33.1) 7.3  (37.1)
Week 12 (N=52, 65) -34.4  (17.2) -36.0  (23.8)
Week 16 (N=5, 5) -59.0  (49.9) -162.2  (198.8)
Week 20 (N=2, 3) 132.6  (127.8) 180.1  (644.4)
Week 24 (N=42, 60) -38.4  (16.7) -29.1  (10.1)
Week 28 (N=12, 13) 11.8  (44.6) -21.2  (30.1)
Week 32 (N=2, 3) -47.2  (36.8) 41.7  (119.5)
Week 36 (N=0, 2) NA [1]   (NA) 41.0  (33.3)
Week 40 (N=8, 2) 2.0  (71.0) 62.2  (76.0)
Week 44 (N=4, 0) 370.5  (405.6) NA [2]   (NA)
Week 48 (N=32, 46) -38.0  (20.7) -14.3  (17.2)
Week 60 (N=1, 3) -13.2 [3]   (NA) 91.0  (66.8)
Week 72 (N=30, 40) -61.4  (17.2) -4.8  (26.3)
[1]
No participants with data in this arm at Week 36.
[2]
No participants with data for this arm at Week 44.
[3]
Only 1 participant with data. Unable to calculate standard error.
11.Secondary Outcome
Title Change From Baseline in Fasting Hemoglobin A1C (HbA1c) Concentrations at Each Time Point Assessed
Hide Description

Blood was collected for a fasting Hemoglobin A1C level at various time points throughout the study and was used as a measure of glycemic control (monitoring the ability of the patient to maintain normal blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: Percent
Week 4 (n=3, 5) -0.4  (0.35) -0.1  (0.22)
Week 8 (n=4, 28) -0.9  (0.13) -1.0  (0.18)
Week 12 (n=50, 65) -1.1  (0.10) -1.5  (0.12)
Week 16 (n=5, 4) -0.8  (0.12) -1.7  (0.64)
Week 20 (n=1, 4) -0.6 [1]   (NA) -1.3  (0.30)
Week 24 (n=41, 51) -1.0  (0.10) -1.5  (0.12)
Week 28 (n=11, 12) -0.7  (0.20) -1.1  (0.17)
Week 32 (n=2, 2) -1.0  (0.40) -1.7  (0.80)
Week 36 (n=0, 2) NA [2]   (NA) -0.5  (0.05)
Week 40 (n=8, 1) -0.3  (0.28) -1.8 [3]   (NA)
Week 44 (n=7, 0) -0.7  (0.22) NA [4]   (NA)
Week 48 (N=31, 46) -0.8  (0.13) -1.1  (0.15)
Week 60 (N=1, 2) -0.2 [3]   (NA) -0.1  (0.30)
Week 72 (N=29, 38) -0.1  (0.10) -0.1  (0.11)
[1]
Only 1 participant unable to calculate standard error.
[2]
No participants with data in this arm for Week 36.
[3]
Only 1 participant with data. Unable to calculate standard error.
[4]
No participants with data in this arm at Week 44.
12.Secondary Outcome
Title Change From Baseline in Homeostasis Model Assessment (HOMA) Scores at Each Time Point Assessed
Hide Description

Insulin resistance (IR) is calculated using the following formula:

HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405.

Baseline for "with pioglitazone" arm occurred prior to the start of 16 week run-in period and for "without pioglitazone" arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the start of anti-HCV therapy is calculated.

A normal patient can have a HOMA score up to 3. A patient with a score of >3 is definitely IR. Patients scoring 2-3 can be IR but other factors may be causing this without being IR.

Time Frame Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: HOMA Score
Week 4 (n=54, 42) 0.6  (1.31) -0.8  (1.52)
Week 8 (n=3, 25) -2.3  (1.74) 0.6  (1.80)
Week 12 (n=51, 63) -2.0  (0.74) -2.1  (1.07)
Week 16 (n=5, 5) -3.2  (2.28) -9.1  (7.96)
Week 20 (n=2, 3) 4.0  (4.60) 10.5  (32.38)
Week 24 (n=42, 60) -1.8  (0.74) -1.3  (0.45)
Week 28 (n=10, 13) 0.8  (1.95) -1.0  (1.36)
Week 32 (n=2, 2) -1.8  (1.27) 4.2  (6.81)
Week 36 (n=0, 2) NA [1]   (NA) 2.0  (0.41)
Week 40 (n=6, 2) 0.2  (4.00) 1.0  (3.91)
Week 44 (n=4, 0) 30.4  (31.74) NA [2]   (NA)
Week 48 (n=30, 44) -1.6  (0.98) -0.3  (0.91)
Week 60 (n=1, 2) 0.6 [3]   (NA) 5.0  (3.83)
Week 72 (n=27, 35) -2.7  (1.01) -0.1  (1.39)
[1]
No participants with data in this arm at Week 36.
[2]
No participants with data in this arm at Week 44.
[3]
Only 1 participant with data. Unable to calculate standard error.
13.Secondary Outcome
Title Change From Baseline in Serum Triglyceride Concentrations at Each Time-point Assessed
Hide Description

Blood was collected and assayed for fasting serum triglyceride levels at various time points throughout the study and was used as an indicator of lipid control.

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60, 72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: mmol/L
Week 4 (n=61, 72) 0.5  (0.21) 0.4  (0.11)
Week 8 (n=58, 69) 0.2  (0.09) 0.5  (0.12)
Week 12 (n=56, 68) 0.2  (0.11) 0.7  (0.23)
Week 16 (n=53, 62) 0.2  (0.08) 0.6  (0.20)
Week 20 (n=46, 59) 0.2  (0.11) 0.6  (0.16)
Week 24 (n=47, 61) 0.5  (0.26) 0.3  (0.10)
Week 28 (n=52, 62) 0.2  (0.10) 0.4  (0.14)
Week 32 (n=38, 47) 0.3  (0.13) 0.5  (0.19)
Week 36 (n=38, 46) 0.1  (0.11) 0.5  (0.15)
Week 40 (n=45, 49) 0.2  (0.12) 0.4  (0.13)
Week 44 (n=37, 43) 0.3  (0.23) 0.3  (0.12)
Week 48 (n=34, 46) 0.2  (0.13) 0.5  (0.18)
Week 60 (n=33, 41) -0.2  (0.11) 0.3  (0.16)
Week 72 (n=30, 39) -0.1  (0.16) 0.2  (0.12)
14.Secondary Outcome
Title Change From Baseline in Total Cholesterol Levels at Each Time-point Assessed
Hide Description

Blood was collected and assayed for fasting serum cholesterol levels at various time points throughout the study and was used as an indicator of lipid control.

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: mmol/L
Week 4 (n=61, 72) -0.2  (0.08) -0.5  (0.07)
Week 8 (n=58, 69) -0.2  (0.07) -0.6  (0.08)
Week 12 (n=56, 68) -0.2  (0.07) -0.6  (0.09)
Week 16 (n=53, 62) -0.3  (0.07) -0.7  (0.11)
Week 20 (n=46, 59) -0.3  (0.08) -0.6  (0.11)
Week 24 (n=47, 61) -0.2  (0.09) -0.7  (0.10)
Week 28 (n=52, 62) -0.3  (0.08) -0.7  (0.10)
Week 32 (n=38, 47) -0.4  (0.10) -0.8  (0.11)
Week 36 (n=38, 46) -0.3  (0.10) -0.7  (0.12)
Week 40 (n=45, 49) -0.3  (0.08) -0.8  (0.12)
Week 44 (n=37, 43) -0.2  (0.11) -0.8  (0.13)
Week 48 (n=34, 46) -0.3  (0.11) -0.7  (0.11)
Week 60 (n=33, 41) 0.0  (0.15) 0.1  (0.14)
Week 72 (n=30, 39) 0.3  (0.15) 0.2  (0.14)
15.Secondary Outcome
Title Change From Baseline in Low-density Lipoprotein (LDL-cholesterol) Levels at Each Time-point Assessed
Hide Description

Blood was collected and assayed for fasting serum low-density lipoprotein (LDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: mmol/L
Week 4 (n=58, 70) -0.3  (0.07) -0.5  (0.07)
Week 8 (n=57, 66) -0.2  (0.06) -0.6  (0.08)
Week 12 (n=55, 62) -0.2  (0.07) -0.5  (0.10)
Week 16 (n=53, 58) -0.2  (0.07) -0.6  (0.10)
Week 20 (n=46, 56) -0.2  (0.07) -0.6  (0.11)
Week 24 (n=45, 60) -0.2  (0.08) -0.6  (0.10)
Week 28 (n=52, 60) -0.2  (0.08) -0.6  (0.09)
Week 32 (N=38, 44) -0.40  (0.09) -0.7  (0.12)
Week 36 (n=37, 44) -0.2  (0.08) -0.7  (0.11)
Week 40 (n=44, 49) -0.3  (0.08) -0.7  (0.11)
Week 44 (n=36, 43) -0.2  (0.08) -0.7  (0.11)
Week 48 (n=34, 44) -0.3  (0.09) -0.7  (0.10)
Week 60 (n=33, 39) 0.1  (0.12) 0.1  (0.13)
Week 72 (n=30, 38) 0.2  (0.10) 0.0  (0.13)
16.Secondary Outcome
Title Change From Baseline in High-density Lipoprotein (HDL-cholesterol) Levels at Each Time-point Assessed
Hide Description

Blood was collected and assayed for fasting high-density lipoprotein (HDL-cholesterol) levels at various time points throughout the study and was used as an indicator of lipid control.

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4,8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: mmol/L
Week 4 (n=61, 72) -0.1  (0.04) -0.1  (0.03)
Week 8 (n=58, 69) -0.1  (0.03) -0.2  (0.03)
Week 12 (n=56, 68) -0.1  (0.03) -0.2  (0.03)
Week 16 (n=53, 62) -0.2  (0.03) -0.2  (0.03)
Week 20 (n=46, 59) -0.1  (0.04) -0.2  (0.04)
Week 24 (n=47, 61) -0.2  (0.03) -0.2  (0.04)
Week 28 (n=52, 62) -0.1  (0.03) -0.2  (0.04)
Week 32 (n=38, 47) -0.2  (0.04) -0.3  (0.04)
Week 36 (n=38, 46) -0.1  (0.04) -0.3  (0.05)
Week 40 (n=45, 49) -0.1  (0.03) -0.3  (0.05)
Week 44 (n=37, 43) -0.1  (0.04) -0.2  (0.05)
Week 48 (n=34, 46) -0.1  (0.05) -0.2  (0.05)
Week 60 (n=33, 41) 0.1  (0.06) -0.1  (0.04)
Week 72 (n=30, 39) 0.2  (0.07) 0.1  (0.04)
17.Secondary Outcome
Title Change From Baseline in Tumor Necrosis Factor Alpha (TNF-α) at Each Time Point Assessed
Hide Description

Blood was collected for tumor necrosis factor alpha at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: pg/mL
Week 4 (n=56, 41) -1.9  (0.88) -0.9  (1.26)
Week 8 (n=5, 25) -3.7  (3.93) 1.1  (0.36)
Week 12 (n=51, 45) -2.0  (0.89) 2.8  (3.84)
Week 16 (n=5, 4) -1.2  (1.74) 0.6  (1.85)
Week 20 (n=2, 3) 0.7  (0.38) -3.5  (3.64)
Week 24 (n=42, 57) -1.1  (1.50) -1.8  (1.31)
Week 28 (n=12, 12) -0.7  (1.73) -0.1  (0.68)
Week 32 (n=2, 2) -0.8  (0.90) -1.0  (0.07)
Week 36 (n=0, 2) NA [1]   (NA) 2.7  (2.66)
Week 40 (n=7, 1) -3.3  (1.58) 3.6 [2]   (NA)
Week 44 (n=4, 0) -2.1  (0.35) NA [3]   (NA)
Week 48 (n=32, 44) -2.5  (0.91) -1.4  (1.33)
Week 60 (n=1, 2) -2.4 [2]   (NA) -1.4  (0.20)
Week 72 (n=29, 37) -3.7  (1.54) -2.0  (0.31)
[1]
No participants with data in this arm for Week 36
[2]
Only 1 participant unable to calculate standard error
[3]
No participants with data in this arm for Week 44
18.Secondary Outcome
Title Change From Baseline in Transforming Growth Factor Beta (TGF-β) Levels at Each Time Point Assessed
Hide Description

Blood was collected for Transforming Growth Factor beta at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: pg/mL
Week 4 (n=56, 41) -14891  (1406) -7256  (1711)
Week 8 (n=5, 25) -16224  (8318) -13955  (2190)
Week 12 (n=51, 45) -17666  (1655) -11447  (2141)
Week 16 (n=5, 4) -6164  (8199) -14570  (4272)
Week 20 (n=2, 3) -10653  (1886) -11290  (10160)
Week 24 (n=42, 57) -15976  (1727) -13875  (1619)
Week 28 (n=12, 12) -4071  (2864) -9242  (3185)
Week 32 (n=2, 2) -19750  (12614) -18973  (5737)
Week 36 (n=0, 2) NA [1]   (NA) 8724  (12181)
Week 40 (n=7, 1) -3119  (4460) 1785 [2]   (NA)
Week 44 (n=4, 0) -6415  (5890) NA [3]   (NA)
Week 48 (n=32, 44) -16510  (2573) -10149  (2285)
Week 60 (n=1, 2) -14539 [2]   (NA) -3612  (5410)
Week 72 (n=29, 37) -6403  (2504) -1347  (2327)
[1]
No participants with data in this arm for Week 36
[2]
Only 1 participant unable to calculate standard error
[3]
No participants with data in this arm for Week 44
19.Secondary Outcome
Title Change From Baseline in Adiponectin Levels at Each Time Point Assessed
Hide Description

Blood was collected for adiponectin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: μg/mL
Week 4 (n=56, 39) 13.0  (1.15) 1.6  (0.80)
Week 8 (n=5, 23) 12.2  (5.11) -1.1  (0.60)
Week 12 (n=49, 45) 10.7  (1.17) 0.3  (0.59)
Week 16 (n=5, 4) 9.0  (2.30) -1.0  (0.41)
Week 20 (n=2, 3) 3.0  (2.00) 4.0  (0.58)
Week 24 (n=41, 55) 12.5  (1.27) 0.2  (0.57)
Week 28 (n=11, 11) 4.4  (2.18) -1.0  (1.39)
Week 32 (n=2, 2) 13.0  (4.00) 1.5  (0.50)
Week 36 (n=0, 2) NA [1]   (NA) 0.0  (1.00)
Week 40 (n=7, 1) 2.9  (1.61) -4.0 [2]   (NA)
Week 44 (n=3, 0) 3.7  (1.67) NA [3]   (NA)
Week 48 (n=31, 44) 10.8  (1.70) 0.3  (0.62)
Week 60 (n=1, 2) -1.0 [2]   (NA) 3.0  (1.00)
Week 72 (n=29, 36) 8.2  (2.07) -0.1  (0.38)
[1]
No participants with data in this arm for Week 36
[2]
Only 1 participant unable to calculate standard error
[3]
No participants with data in this arm for Week 44
20.Secondary Outcome
Title Change From Baseline in Leptin Levels at Each Time Point Assessed
Hide Description

Blood was collected for leptin at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: ng/mL
Week 4 (n=56, 39) -1.8  (1.38) -2.4  (0.73)
Week 8 (n=5, 22) -1.9  (1.43) -3.0  (0.89)
Week 12 (n=48, 44) -3.1  (1.38) -3.8  (1.01)
Week 16 (n=5, 4) -6.4  (6.67) -7.9  (7.37)
Week 20 (n=2, 3) -2.9  (0.70) -4.0  (1.85)
Week 24 (n=42, 54) -5.8  (1.55) -5.0  (0.84)
Week 28 (n=11, 11) -3.7  (2.05) -4.1  (1.93)
Week 32 (n=2, 2) -4.5  (1.10) -4.9  (0.90)
Week 36 (n=0, 2) NA [1]   (NA) -1.5  (1.20)
Week 40 (n=7, 1) -4.8  (2.32) 11.5 [2]   (NA)
Week 44 (n=3, 0) 6.0  (8.70) NA [3]   (NA)
Week 48 (n=31, 43) -4.6  (1.31) -5.5  (1.25)
Week 60 (n=1, 2) 3.4 [2]   (NA) -0.6  (1.50)
Week 72 (n=29, 36) 1.3  (2.12) 1.4  (1.17)
[1]
No participants with data in this arm for Week 36
[2]
Only 1 participant unable to calculate standard error
[3]
No participants with data in this arm for Week 44
21.Secondary Outcome
Title Change From Baseline in Free Fatty Acid Levels at Each Time Point Assessed
Hide Description

Blood was collected for free fatty acids at various time points throughout the study and was used as a measure of insulin resistance (the inability of insulin to control blood sugar levels).

Baseline for the with pioglitazone arm occurred prior to the start of 16 week run-in period and for the without pioglitazone arm prior to the start of anti-HCV therapy. The change from baseline to Weeks 4 thru 72 after the initiation of anti-HCV therapy is calculated.

Time Frame Baseline, Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to Treat population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 73
Mean (Standard Error)
Unit of Measure: mmol/L
Week 4 (n=55, 35) 0.0  (0.09) 0.1  (0.05)
Week 8 (n=2, 2) -0.1  (0.08) 0.0  (0.31)
Week 12 (n=52, 32) -0.0  (0.07) 0.2  (0.12)
Week 16 (n=5, 3) -0.0  (0.16) -0.1  (0.26)
Week 20 (n=2, 3) -0.5  (0.34) 0.1  (0.38)
Week 24 (n=40, 31) -0.1  (0.09) 0.2  (0.05)
Week 28 (n=11, 5) 0.0  (0.09) 0.1  (0.13)
Week 32 (n=2, 1) 0.3  (0.12) -0.4 [1]   (NA)
Week 36 (n=0, 1) NA [2]   (NA) 0.2 [1]   (NA)
Week 40 (n=8, 1) 0.2  (0.31) -0.3 [1]   (NA)
Week 44 (n=4, 0) -0.0  (0.05) NA [3]   (NA)
Week 48 (n=32, 24) -0.2  (0.09) 0.0  (0.05)
Week 60 (n=1, 0) 0.1 [1]   (NA) NA [4]   (NA)
Week 72 (n=30, 19) -0.2  (0.11) 0.1  (0.07)
[1]
Only 1 participant unable to calculate standard error
[2]
No participants with data in this arm for Week 36
[3]
No participants with data in this arm for Week 44
[4]
No participants with data in this arm for Week 60
22.Secondary Outcome
Title Percentage of Participants With Beck Depression Inventory Fast Screen (BDI-FS) Score ≥ 4 at Each Time Point Assessed
Hide Description The BDI-FS consisted of seven areas with four statements (labeled 0, 1, 2, and 3) offered to describe the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score. The degree of depression was assessed with 0 to 3 indicating minimal depression, 4 to 8 mild depression, 9 to 12 moderate depression and 13 to 21 severe depression.
Time Frame Weeks 4, 8,12,16,20,24,28,32,36,40,44,48,60,72
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety population who received at least one dose of study drug and who had data available at the given time point for analysis.
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description:
Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
Overall Number of Participants Analyzed 77 75
Measure Type: Number
Unit of Measure: Percentage of Participants
Week 4 (n=61, 71) 6.6 12.7
Week 8 (n=57, 69) 5.3 7.2
Week 12 (n=55, 67) 10.9 11.9
Week 16 (n=50, 62) 6.0 4.8
Week 20 (n=46, 59) 8.7 3.4
Week 24 (n=45, 60) 2.2 10.0
Week 28 (n=46, 59) 8.7 3.4
Week 32 (n=37, 46) 5.4 4.3
Week 36 (n=37, 46) 5.4 6.5
Week 40 (n=42, 44) 4.8 2.3
Week 44 (n=36, 40) 0 2.5
Week 48 (n=32, 45) 0 0
Week 60 (n=1, 3) 0 33.3
Week 72 (n=30, 39) 3.3 7.7
Time Frame 72 weeks for those patients who participated in the 48 week anti-HCV treatment period and the 24 week follow-up period plus an additional 16 weeks for those participants in the arm that received pioglitazone for 16 weeks during the run-in period.
Adverse Event Reporting Description Safety population includes participants who received at least one dose of study drug and who had at least one post baseline safety assessment.
 
Arm/Group Title PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Hide Arm/Group Description Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period. Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
All-Cause Mortality
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   10/77 (12.99%)   9/75 (12.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/77 (1.30%)  0/75 (0.00%) 
Pancytopenia  1  1/77 (1.30%)  0/75 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  0/77 (0.00%)  1/75 (1.33%) 
Eye disorders     
Retinopathy  1  0/77 (0.00%)  1/75 (1.33%) 
Gastrointestinal disorders     
Megacolon  1  0/77 (0.00%)  1/75 (1.33%) 
Obstruction gastric  1  0/77 (0.00%)  1/75 (1.33%) 
Pancreatitis acute  1  1/77 (1.30%)  0/75 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/77 (1.30%)  0/75 (0.00%) 
Hepatic cirrhosis  1  0/77 (0.00%)  1/75 (1.33%) 
Hepatitis acute  1  1/77 (1.30%)  0/75 (0.00%) 
Infections and infestations     
Pneumonia  1  1/77 (1.30%)  2/75 (2.67%) 
Appendicitis  1  1/77 (1.30%)  1/75 (1.33%) 
Bacteraemia  1  1/77 (1.30%)  0/75 (0.00%) 
Device related sepsis  1  1/77 (1.30%)  0/75 (0.00%) 
Gastroenteritis  1  0/77 (0.00%)  1/75 (1.33%) 
Gastroenteritis viral  1  1/77 (1.30%)  0/75 (0.00%) 
Injury, poisoning and procedural complications     
Lower limb fracture  1  1/77 (1.30%)  0/75 (0.00%) 
Spinal cord injury cervical  1  1/77 (1.30%)  0/75 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  1/77 (1.30%)  0/75 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/77 (1.30%)  0/75 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/77 (0.00%)  1/75 (1.33%) 
Lung neoplasm malignant  1  1/77 (1.30%)  0/75 (0.00%) 
Nervous system disorders     
Syncope  1  0/77 (0.00%)  1/75 (1.33%) 
Psychiatric disorders     
Suicidal ideation  1  2/77 (2.60%)  1/75 (1.33%) 
Panic attack  1  1/77 (1.30%)  0/75 (0.00%) 
Suicide attempt  1  1/77 (1.30%)  0/75 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  1/77 (1.30%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  1/77 (1.30%)  0/75 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-INF Alpha-2a + Ribavirin+ Pioglitazone PEG-INF Alpha-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%)
Total   68/77 (88.31%)   75/75 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  27/77 (35.06%)  24/75 (32.00%) 
Neutropenia  1  15/77 (19.48%)  12/75 (16.00%) 
Lymphadenopathy  1  2/77 (2.60%)  4/75 (5.33%) 
Thrombocytopenia  1  4/77 (5.19%)  2/75 (2.67%) 
Eye disorders     
Vision blurred  1  4/77 (5.19%)  5/75 (6.67%) 
Gastrointestinal disorders     
Nausea  1  26/77 (33.77%)  21/75 (28.00%) 
Diarrhoea  1  9/77 (11.69%)  10/75 (13.33%) 
Vomiting  1  6/77 (7.79%)  9/75 (12.00%) 
Constipation  1  6/77 (7.79%)  6/75 (8.00%) 
Dyspepsia  1  4/77 (5.19%)  5/75 (6.67%) 
Gastrooesophageal reflux disease  1  3/77 (3.90%)  5/75 (6.67%) 
Dry mouth  1  1/77 (1.30%)  6/75 (8.00%) 
Haemorrhoids  1  1/77 (1.30%)  5/75 (6.67%) 
Abdominal pain  1  1/77 (1.30%)  4/75 (5.33%) 
Toothache  1  4/77 (5.19%)  1/75 (1.33%) 
General disorders     
Fatigue  1  30/77 (38.96%)  35/75 (46.67%) 
Influenza like illness  1  13/77 (16.88%)  12/75 (16.00%) 
Pyrexia  1  12/77 (15.58%)  7/75 (9.33%) 
Injection site erythema  1  1/77 (1.30%)  17/75 (22.67%) 
Irritability  1  8/77 (10.39%)  7/75 (9.33%) 
Pain  1  12/77 (15.58%)  3/75 (4.00%) 
Chills  1  6/77 (7.79%)  5/75 (6.67%) 
Injection site reaction  1  1/77 (1.30%)  6/75 (8.00%) 
Oedema peripheral  1  5/77 (6.49%)  2/75 (2.67%) 
Infections and infestations     
Upper respiratory tract infection  1  8/77 (10.39%)  5/75 (6.67%) 
Urinary tract infection  1  6/77 (7.79%)  2/75 (2.67%) 
Bronchitis  1  6/77 (7.79%)  1/75 (1.33%) 
Nasopharyngitis  1  5/77 (6.49%)  0/75 (0.00%) 
Investigations     
Weight decreased  1  3/77 (3.90%)  8/75 (10.67%) 
Weight increased  1  4/77 (5.19%)  0/75 (0.00%) 
White blood cell count decreased  1  4/77 (5.19%)  0/75 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  10/77 (12.99%)  8/75 (10.67%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  9/77 (11.69%)  12/75 (16.00%) 
Myalgia  1  5/77 (6.49%)  10/75 (13.33%) 
Back pain  1  2/77 (2.60%)  7/75 (9.33%) 
Muscle spasms  1  7/77 (9.09%)  2/75 (2.67%) 
Pain in extremity  1  5/77 (6.49%)  0/75 (0.00%) 
Nervous system disorders     
Headache  1  14/77 (18.18%)  20/75 (26.67%) 
Dizziness  1  12/77 (15.58%)  12/75 (16.00%) 
Dysgeusia  1  5/77 (6.49%)  3/75 (4.00%) 
Psychiatric disorders     
Insomnia  1  21/77 (27.27%)  23/75 (30.67%) 
Depression  1  9/77 (11.69%)  23/75 (30.67%) 
Anxiety  1  2/77 (2.60%)  9/75 (12.00%) 
Suicidal ideation  1  5/77 (6.49%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  11/77 (14.29%)  12/75 (16.00%) 
Dyspnoea  1  4/77 (5.19%)  4/75 (5.33%) 
Skin and subcutaneous tissue disorders     
Rash  1  11/77 (14.29%)  19/75 (25.33%) 
Pruritus  1  15/77 (19.48%)  13/75 (17.33%) 
Dry skin  1  8/77 (10.39%)  14/75 (18.67%) 
Alopecia  1  3/77 (3.90%)  11/75 (14.67%) 
Rash maculo-papular  1  1/77 (1.30%)  5/75 (6.67%) 
Pruritus generalised  1  1/77 (1.30%)  4/75 (5.33%) 
Vascular disorders     
Hypertension  1  2/77 (2.60%)  5/75 (6.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545233    
Other Study ID Numbers: ML21301
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: February 8, 2012
Results First Posted: May 7, 2012
Last Update Posted: May 7, 2012