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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis C and Chronic Renal Failure.

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ClinicalTrials.gov Identifier: NCT00474955
Recruitment Status : Completed
First Posted : May 17, 2007
Results First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Intervention Drug: peginterferon alfa-2a [Pegasys]
Enrollment 27
Recruitment Details A total of 27 participants were enrolled in this study conducted from 2006 to 2011 at 5 centers in Russian Federation.
Pre-assignment Details  
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description Eligible participants were administered peginterferon alpha-2a [Pegasys] [40 kilo Dalton (kDa)], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of <15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Period Title: Overall Study
Started 27
Completed 19
Not Completed 8
Reason Not Completed
Adverse Event             2
Drug unavailability             1
Personal reasons             5
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all enrolled participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
44  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
16
  59.3%
Male
11
  40.7%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion
Hide Description Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (<50 international units [IU]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).
Time Frame At Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Percentage of participants
55.6
2.Primary Outcome
Title Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48
Hide Description HCV RNA level less than 50 IU/mL was considered to be undetectable.
Time Frame At Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Percentage of participants
At Week 24 59.3
At Week 48 48.1
3.Primary Outcome
Title Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline
Hide Description The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit [Days -30 to -1]).
Time Frame From Baseline (Days -30 to -1) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Percentage of participants
33.3
4.Secondary Outcome
Title Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events
Hide Description An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
Participants with any AEs 10
Participants with any SAEs 2
5.Secondary Outcome
Title Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks
Hide Description Participants who prematurely withdrew from the treatment for the following reasons: personal reasons (not related to the study), adverse events, and drug unavailability, are presented.
Time Frame Up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
Personal reasons (not related to the study) 5
Adverse events 2
Drug unavailability 1
6.Secondary Outcome
Title Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks
Hide Description Marked abnormal laboratory parameters included serum glutamic pyruvic transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT), gamma-glutamyl transpeptidase (GGTP), total bilirubin, alkaline phosphatase (ALP), ferritin and transferrin saturation. These laboratory parameters were evaluated at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 0 (V1), Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least one dose of study medication.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
SGPT Increased, Baseline 6
SGPT Increased, V1 5
SGPT Increased, V2 4
SGPT Increased, V3 4
SGPT Increased, V4 6
SGPT Increased, V5 8
SGPT Increased, V6 5
SGPT Increased, V7 2
SGPT Increased, V8 4
SGPT Increased, V9 3
SGPT Increased, V10 3
SGOT Increased, Baseline 4
SGOT Increased, V3 2
GGTP Increased, V3 1
Total bilirubin Increased, Baseline 1
ALP Increased Baseline 7
ALP Increased, V3 9
Ferritin Increased, Baseline 18
Ferritin Decreased, Baseline 1
Ferritin Increased, V1 18
Ferritin Increased, V4 17
Ferritin Increased, V5 14
Ferritin Increased, V7 14
Transferrin saturation Increased, Baseline 7
Transferrin saturation Decreased, Baseline 2
Transferrin saturation Increased, V1 8
Transferrin saturation Decreased, V1 1
Transferrin saturation Increased, V4 7
Transferrin saturation Increased, V5 4
Transferrin saturation Decreased, V5 1
Transferrin saturation Increased, V7 7
7.Secondary Outcome
Title Mean Change From Baseline in Blood Pressure up to Week 72
Hide Description Mean change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) was recorded at Baseline (Screening visit [Days -30 to -1]) and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7) and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Time Frame From Baseline (Days -30 to -1) to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by 'n'.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Millimeter (mm) of Mercury
DBP, V2, n=27 -0.7  (8.6)
DBP, V3, n=27 0.6  (12.1)
DBP, V4, n=26 -2.9  (7.2)
DBP, V5, n=23 -1.3  (10.1)
DBP, V6, n=23 -2.6  (9.0)
DBP, V7, n=19 -3.7  (9.6)
DBP, V8, n=27 -4.6  (8.1)
DBP, V9, n=21 -3.6  (9.1)
DBP, V10, n=21 -3.8  (9.2)
SBP, V2, n=27 -2.8  (12.9)
SBP, V3, n=27 1.3  (15.6)
SBP, V4, n=26 -4.0  (11.6)
SBP, V5, n=23 -0.7  (12.0)
SBP, V6, n=23 -0.4  (10.3)
SBP, V7, n=19 -4.2  (13.2)
SBP, V8, n=27 -5.2  (11.3)
SBP, V9, n=21 -3.1  (17.4)
SBP, V10, n=21 -4.5  (14.7)
8.Secondary Outcome
Title Mean Change From Baseline in Heart Rate up to Week 72
Hide Description Mean change from baseline in heart rate was recorded at Baseline (Screening visit [Days -30 to -1]), and at various Visits (V): Week 2 (V2), Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6) and Week 48 (V7), and after treatment completion at follow-up (FU) Week 4 (Week 52, V8), FU Week 12 (Week 60, V9), and FU Week 24 (Week 72, V10).
Time Frame From Baseline (Days -30 to -1) to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all enrolled participants who received at least one dose of study medication. Number of participants evaluable at a particular visit was determined by 'n'.
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description:
Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: Beats per minute (bpm)
V2, n=27 0.7  (4.9)
V3, n=27 1.5  (4.2)
V4, n=26 2.6  (7.9)
V5, n=23 1.1  (5.6)
V6, n=23 0.5  (6.0)
V7, n=19 1.3  (6.4)
V8, n=27 2.0  (5.2)
V9, n=21 1.4  (3.1)
V10, n=21 -0.2  (4.4)
Time Frame Up to Week 72
Adverse Event Reporting Description All SAEs and AEs were collected for safety population included all enrolled participants who received at least one dose of study medication, whether withdrawn prematurely or not, and who had at least one follow-up data point were included.
 
Arm/Group Title Peginterferon Alpha-2a
Hide Arm/Group Description Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
All-Cause Mortality
Peginterferon Alpha-2a
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Peginterferon Alpha-2a
Affected / at Risk (%)
Total   2/27 (7.41%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  1/27 (3.70%) 
Injury, poisoning and procedural complications   
Right acromioclavicular joint dislocation  1  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra version 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Peginterferon Alpha-2a
Affected / at Risk (%)
Total   10/27 (37.04%) 
Blood and lymphatic system disorders   
Neutropenia  1  2/27 (7.41%) 
Thrombocytopenia  1  2/27 (7.41%) 
Gastrointestinal disorders   
Nausea  1  4/27 (14.81%) 
Hepatobiliary disorders   
Cholecystitis  1  1/27 (3.70%) 
Investigations   
Alanine aminotransferase increased  1  1/27 (3.70%) 
Skin and subcutaneous tissue disorders   
Erythema nodosum  1  1/27 (3.70%) 
Weber-Christian disease  1  1/27 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra version 17.1
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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00474955    
Other Study ID Numbers: ML20434
First Submitted: May 16, 2007
First Posted: May 17, 2007
Results First Submitted: April 22, 2016
Results First Posted: July 25, 2016
Last Update Posted: July 25, 2016