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SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).

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ClinicalTrials.gov Identifier: NCT00442572
Recruitment Status : Completed
First Posted : March 2, 2007
Results First Posted : April 11, 2016
Last Update Posted : April 6, 2017
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 B, Chronic
Intervention Drug: PEGASYS [peginterferon alfa-2a]
Enrollment 21
Recruitment Details All participants in this study were enrolled at one centre in Bulgaria from 03 July 2006 to 23 April 2012. Of the 21 participants enrolled, 17 participants were randomized to PEGASYS arm and 4 participants were randomized to no intervention arm.
Pre-assignment Details  
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a (PEGASYS®). Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms (µg) in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously (SC) and followed by 12 weeks period without treatment. Participants were on non- specific anti-viral treatment.
Period Title: Overall Study
Started 17 4
Completed 9 1
Not Completed 8 3
Reason Not Completed
Relapse             8             1
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
Arm/Group Title PEGASYS No Intervention Total
Hide Arm/Group Description Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment. Participants were on non- specific anti-viral treatment. Total of all reporting groups
Overall Number of Baseline Participants 17 4 21
Hide Baseline Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants 4 participants 21 participants
44
(23 to 61)
38.5
(22 to 50)
42
(22 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 4 participants 21 participants
Female
7
  41.2%
0
   0.0%
7
  33.3%
Male
10
  58.8%
4
 100.0%
14
  66.7%
1.Primary Outcome
Title Percentage of Participants With Stable Virological Response
Hide Description Stable virological response is serum Hepatitis B virus deoxyribonucleic acid (HBV DNA) <20 000 copies/ml during the treatment (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment..
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 17 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Week 12
100
(80.49 to 100.00)
100.0
(29.24 to 100.00)
Week 24
52.9
(27.81 to 77.02)
66.7
(9.42 to 99.16)
Week 36
52.9
(27.81 to 77.02)
100.0
(29.24 to 100.00)
Week 48
47.1
(22.98 to 72.19)
66.7
(9.42 to 99.16)
Week 60
47.1
(22.98 to 72.19)
33.3
(0.84 to 90.58)
Week 72
41.2
(18.44 to 67.08)
33.3
(0.84 to 90.58)
Week 84
41.2
(18.44 to 67.08)
33.3
(0.84 to 90.58)
Week 96
29.4
(10.31 to 55.96)
33.3
(0.84 to 90.58)
Week 108
29.4
(10.31 to 55.96)
33.3
(0.84 to 90.58)
2.Secondary Outcome
Title Percentage of Participants With Stable Virological and Biochemical Response
Hide Description All participants who achieved virological response (serum HBV DNA < 20 000 copies/ml) and biochemical response (stable normalization of their alanine transaminase [ALT]) during the treatment cycle (after each 12 weeks) and after the follow-up period (24 weeks after the last treatment period).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 17 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Week 12
100.0
(80.49 to 100.00)
100.0
(29.24 to 100.00)
Week 24
52.9
(27.81 to 77.02)
66.7
(9.42 to 99.16)
Week 36
52.9
(27.81 to 77.02)
100.0
(29.24 to 100.00)
Week 48
47.1
(22.98 to 72.19)
66.7
(9.42 to 99.16)
Week 60
47.1
(22.98 to 72.19)
33.3
(0.84 to 90.58)
Week 72
41.2
(18.44 to 67.08)
33.3
(0.84 to 90.58)
Week 84
41.2
(18.44 to 67.08)
33.3
(0.84 to 90.58)
Week 96
29.4
(10.31 to 55.96)
33.3
(0.84 to 90.58)
Week 108
29.4
(10.31 to 55.96)
33.3
(0.84 to 90.58)
3.Secondary Outcome
Title Percentage of Participants With Loss of Hepatitis B Surface Antigen
Hide Description Loss of Hepatitis B Surface Antigen (HBsAg) was defined as change of detectable HBsAg from positive to negative.
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 17 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
5.9
(0.14 to 28.69)
0
(0 to 0)
4.Secondary Outcome
Title Percentage of Participants With HBsAg Seroconversion
Hide Description The development of antibodies against HBsAg is known as HBsAg seroconversion. It signifies clearance of HBsAg and resolution of the chronic infection. НBsAg seroconversion is the final goal of anti-hepatitis B virus treatment and it is closest to the definition of “cure” but in practice it is very rare in HBeAg-negative chronic hepatitis B (CHB).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis. Only participants with HBsAg clearance were analyzed.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: Percentage of Participants
0
5.Secondary Outcome
Title Percentage of Participants With HBV DNA Levels Under the Lower Limit (Serum HBV DNA Level < 300 Copies/ml) For a Significant Quantity
Hide Description HBV DNA level, or viral load, is an indicator of viral replication. Higher HBV DNA levels are usually associated with an increased risk of liver disease and hepatocellular carcinoma. HBV DNA level typically falls in response to effective antiviral treatment.
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who passed during at least one treatment period and had at least one efficacy and safety evaluation. HBV DNA levels below lower limit for significant quantity were not studied for no intervention arm participants.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 17 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
29.4
(10.3 to 56.0)
6.Secondary Outcome
Title Fibrosis-4 and Aspartate Aminotransferase to Platelet Ratio Index Scores For Change in Liver Fibrosis
Hide Description Fibrosis-4 (FIB-4) and Aspartate Aminotransferase to Platelet Ratio Index (APRI) are non-invasive scoring systems, which are calculated on the basis of laboratory tests that indicates the level of liver fibrosis. The APRI scores are calculated based on Aspartate Aminotransferase (AST) levels and platelet counts whereas FIB-4 scores are calculated based on platelets, ALT, AST and age. For APRI, the scores are interpreted as ≤ 0.5 is 81% sensitive and 50% specific for a diagnosis of significant fibrosis in chronic hepatitis C (CHC), where as a cut-off > 1.5 is 35% sensitive and 91% specific for the diagnosis of significant fibrosis. The majority of biomarker panels will produce inconclusive results for a proportion of participants falling within the indeterminate range (between 0.5 and 1.5) for a specific fibrosis end-point. For FIB-4, the scores are interpreted as FIB-4 score of < 1.45: absence of cirrhosis, FIB-4 score of 1.45 to 3.25: inconclusive, FIB-4 score > 3.25: cirrhosis.
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 13 0
Median (Full Range)
Unit of Measure: Units on a scale
FIB-4
1.06
(0.36 to 2.66)
APRI
0.25
(0.14 to 1.48)
7.Secondary Outcome
Title Mean Change From Baseline in HBsAg Levels
Hide Description An early decrease in HBsAg from baseline to Weeks 12 or 24 has been identified as further on-treatment predictor for sustained HBsAg clearance and virological response in HBeAg negative participants.
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation. Data of participants available at the time of the assessment were included in the analysis.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 17 3
Mean (95% Confidence Interval)
Unit of Measure: copies/mL
Week 12, n=17,3
-1156.00
(-5212.33 to 2900.33)
-240.50
(-3715.65 to 3234.65)
Week 24, n=17,3
-1293.72
(-5756.89 to 3169.45)
-146.00
(-7172.53 to 6880.53)
Week 36, n=14,3
-3049.64
(-7949.30 to 1850.01)
-564.00
(-4248.80 to 3120.80)
Week 48, n=13, 3
-1591.78
(-9217.83 to 6034.28)
-528.50
(-2987.15 to 1930.15)
Week 60, n=11,1
-3096.56
(-11135.37 to 4942.26)
-379.00 [1] 
(NA to NA)
Week 72, n=10, 1
-3485.90
(-10299.06 to 3327.26)
-34.00 [2] 
(NA to NA)
Week 84, n=9, 1
201.40
(-11899.81 to 12302.61)
-54.72 [3] 
(NA to NA)
Week 96, n=14,1
-3011.75
(-8046.71 to 2023.21)
-49.51 [4] 
(NA to NA)
Week 108, n=12,0
-3368.13
(-7625.12 to 888.87)
NA [5] 
(NA to NA)
[1]
For Week 60, only one participant had valid data based on which 95% CI cannot be constructed.
[2]
For Week 72, only one participant had valid data based on which 95% CI cannot be constructed.
[3]
For Week 84, only one participant had valid data based on which 95% CI cannot be constructed.
[4]
For Week 96, only one participant had valid data based on which 95% CI cannot be constructed.
[5]
For Week 108, none of the participants contributed data for analysis of HBsAg levels.
8.Secondary Outcome
Title Mean Change From Baseline in Hemoglobin
Hide Description The hemoglobin values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: Gram/deciliter
-1.73  (10.44)
9.Secondary Outcome
Title Mean Change From Baseline in Hematology
Hide Description The hematology parameters included erythrocytes, leucocytes, basophils, eosinophils, lymphocytes, monocytes, thrombocytes. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: 10^9/L
Erythrocytes 0.08  (0.26)
Leukocytes -1.72  (2.00)
Basophils -0.18  (0.38)
Lymphocytes 5.56  (6.31)
Monocytes 1.87  (3.10)
Thrombocytes -31.20  (36.40)
Eosinophils 0.92  (1.24)
10.Secondary Outcome
Title Mean Change From Baseline in Clinical Chemistry
Hide Description The clinical chemistry parameters included alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP). All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: Units/Litre
ALAT 5.56  (25.44)
ASAT 9.00  (27.76)
GGT 1.00  (3.70)
ALP 50.92  (38.00)
11.Secondary Outcome
Title Mean Change From Baseline in Protein and Indirect Albumin
Hide Description The clinical chemistry parameters included indirect protein and albumin. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and no intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: Gram/deciliter
Protein indirect -31.62  (38.70)
Albumin -1.35  (1.71)
12.Secondary Outcome
Title Mean Change From Baseline in Bilirubin Indirect and Bilirubin Direct
Hide Description The laboratory parameters included bilirubin indirect and bilirubin direct. All laboratory parameters were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: milligrams/deciliter
Indirect bilirubin -0.95  (3.38)
Direct bilirubin -0.16  (0.77)
13.Secondary Outcome
Title Mean Change From Baseline in Blood Urea
Hide Description The blood urea was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: millimoles/liter
-0.34  (1.23)
14.Secondary Outcome
Title Mean Change From Baseline in Creatinine and Uric Acid
Hide Description The creatinine and uric acid values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: micromole/liter
Creatinine -3.65  (13.23)
Uric acid -21.51  (130.42)
15.Secondary Outcome
Title Mean Change From Baseline in Blood Glucose
Hide Description The blood glucose was measured for change from baseline. All blood glucose values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: millimoles/ liter
-0.06  (0.40)
16.Secondary Outcome
Title Mean Change From Baseline in Thyroid Stimulating Hormone (TSH)
Hide Description The TSH was planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: milli-international units/liter
0.67  (1.50)
17.Secondary Outcome
Title Mean Change From Baseline in Triiodothyronine and Thyroxine
Hide Description The Triiodothyronine (T3) and thyroxine (T4) values were planned to be calculated as arithmetic mean by treatment groups (PEGASYS and No Intervention).
Time Frame Up to Week 108
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all the randomized participants who passed during at least one treatment period, and had at least one efficacy and safety evaluation.
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description:
Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
Participants were on non- specific anti-viral treatment.
Overall Number of Participants Analyzed 12 0
Mean (Standard Deviation)
Unit of Measure: picomole/liter
T3, Week 108 0.19  (5.44)
T4, Week 108 -0.85  (4.99)
Time Frame Up to Week 108
Adverse Event Reporting Description AE is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.
 
Arm/Group Title PEGASYS No Intervention
Hide Arm/Group Description Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment. Participants were on non- specific anti-viral treatment.
All-Cause Mortality
PEGASYS No Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEGASYS No Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEGASYS No Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   11/17 (64.71%)   1/4 (25.00%) 
Endocrine disorders     
Hypothyroidism  1  1/17 (5.88%)  0/4 (0.00%) 
Gastrointestinal disorders     
Dental and gingival conditions  1  1/17 (5.88%)  1/4 (25.00%) 
Diarrhea  1  2/17 (11.76%)  0/4 (0.00%) 
Nausea and vomiting symptoms  1  1/17 (5.88%)  0/4 (0.00%) 
Stomach ache  1  1/17 (5.88%)  0/4 (0.00%) 
General disorders     
Fatigue  1  2/17 (11.76%)  0/4 (0.00%) 
Pyrexia  1  3/17 (17.65%)  0/4 (0.00%) 
Immune system disorders     
Allergic Rhinitis  1  1/17 (5.88%)  0/4 (0.00%) 
Infections and infestations     
Herpes simplex  1  2/17 (11.76%)  0/4 (0.00%) 
Viral infection  1  1/17 (5.88%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle pain  1  3/17 (17.65%)  0/4 (0.00%) 
Joint ache  1  1/17 (5.88%)  0/4 (0.00%) 
Arthralgia  1  1/17 (5.88%)  0/4 (0.00%) 
Nervous system disorders     
Headache  1  2/17 (11.76%)  1/4 (25.00%) 
Psychiatric disorders     
Adjustment disorder with mixed anxiety and depressed mood  1  1/17 (5.88%)  0/4 (0.00%) 
Renal and urinary disorders     
Renal colic  1  1/17 (5.88%)  0/4 (0.00%) 
Urinary incontinence  1  1/17 (5.88%)  0/4 (0.00%) 
Reproductive system and breast disorders     
Dysmenorrhea  1  2/17 (11.76%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Tonsilllitis bacterial  1  1/17 (5.88%)  0/4 (0.00%) 
Expectoration  1  2/17 (11.76%)  0/4 (0.00%) 
Sore throat  1  1/17 (5.88%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders     
Hair loss  1  1/17 (5.88%)  0/4 (0.00%) 
Surgical and medical procedures     
Open wound of knee, leg (except thigh), and ankle, without mention of complication  1  1/17 (5.88%)  0/4 (0.00%) 
Vascular disorders     
Hypertonia  1  1/17 (5.88%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00442572     History of Changes
Other Study ID Numbers: ML20020
First Submitted: February 15, 2007
First Posted: March 2, 2007
Results First Submitted: December 8, 2015
Results First Posted: April 11, 2016
Last Update Posted: April 6, 2017