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Trial record 88 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT00394277
Recruitment Status : Completed
First Posted : October 31, 2006
Results First Posted : July 5, 2010
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: peginterferon alfa-2a
Drug: Ribavirin
Enrollment 1175
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Hide Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Period Title: Overall Study
Started 195 196 393 391
Completed 137 136 273 266
Not Completed 58 60 120 125
Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg Total
Hide Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. Total of all reporting groups
Overall Number of Baseline Participants 195 196 393 391 1175
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants 196 participants 393 participants 391 participants 1175 participants
46.1  (9.86) 45.1  (9.50) 45.7  (9.64) 46.0  (10.18) 45.7  (9.83)
[1]
Measure Description: Intent-to-treat population (all patients treated with at least one dose of either study medication) PEG-IFN 180 µg + Ribavirin 1200 mg: n = 191 PEG-IFN 180 µg + Ribavirin 1400/1600 mg: n = 189 PEG-IFN 360/180 µg + Ribavirin 1200 mg: n = 382 PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg: n = 383
Gender   [1] 
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 195 participants 196 participants 393 participants 391 participants 1175 participants
Female 37 41 90 73 241
Male 154 148 292 310 904
[1]
Measure Description: Intent-to-treat population (all patients treated with at least one dose of either study medication) PEG-IFN 180 µg + Ribavirin 1200 mg: n = 191 PEG-IFN 180 µg + Ribavirin 1400/1600 mg: n = 189 PEG-IFN 360/180 µg + Ribavirin 1200 mg: n = 382 PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg: n = 383
1.Primary Outcome
Title Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
Hide Description SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all patients treated with at least one dose of either study medication)
Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Hide Arm/Group Description:
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Overall Number of Participants Analyzed 191 189 382 383
Measure Type: Number
Unit of Measure: Percentage of patients
37.7 42.9 43.5 40.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Comments This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.584
Comments All secondary comparisons were tested at a two-sided significance level of 0.05.
Method Cochran-Mantel-Haenszel
Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.075
Confidence Interval 95%
0.831 to 1.391
Estimation Comments [Not Specified]
2.Secondary Outcome
Title SVR-24 (Actual Treatment Period)
Hide Description SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.
Time Frame 24 weeks after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all patients treated with at least one dose of either study medication)
Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Hide Arm/Group Description:
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Overall Number of Participants Analyzed 191 189 382 383
Measure Type: Number
Unit of Measure: Percentage of patients
38.2 43.9 43.5 40.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Comments (PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.775
Comments All secondary comparisons are tested at a two-sided significance level of 0.05.
Method Cochran-Mantel-Haenszel
Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.039
Confidence Interval 95%
0.803 to 1.344
Estimation Comments [Not Specified]
3.Secondary Outcome
Title SVR-12 (Scheduled Treatment Period)
Hide Description SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).
Time Frame 12 weeks after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all patients treated with at least one dose of either study medication)
Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Hide Arm/Group Description:
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Overall Number of Participants Analyzed 191 189 382 383
Measure Type: Number
Unit of Measure: Percentage of patients
40.3 45.0 44.2 41.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Comments (PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.973
Comments All secondary comparisons are tested at a two-sided significance level of 0.05.
Method Cochran-Mantel-Haenszel
Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.004
Confidence Interval 95%
0.777 to 1.299
Estimation Comments [Not Specified]
4.Secondary Outcome
Title SVR-12 (Actual Treatment Period)
Hide Description SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.
Time Frame 12 weeks after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (all patients treated with at least one dose of either study medication)
Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Hide Arm/Group Description:
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
Overall Number of Participants Analyzed 191 189 382 383
Measure Type: Number
Unit of Measure: Percentage of patients
40.3 45.5 44.2 42.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN 180 µg + Ribavirin 1200 mg, PEG-IFN 180 µg + Ribavirin 1400/1600 mg, PEG-IFN 360/180 µg + Ribavirin 1200 mg, PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Comments (PEG-IFN 180 µg + Ribavirin 1200 mg and PEG-IFN 180 µg + Ribavirin 1400/1600 mg) vs. (PEG-IFN 360/180 µg + Ribavirin 1200 mg and PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.951
Comments All secondary comparisons are tested at a two-sided significance level of 0.05.
Method Cochran-Mantel-Haenszel
Comments P-value obtained from CMH test, stratified by country and ribavirin dose strata.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.008
Confidence Interval 95%
0.780 to 1.304
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Hide Arm/Group Description PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg. PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily). PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
All-Cause Mortality
PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/191 (11.52%)   20/189 (10.58%)   36/382 (9.42%)   39/383 (10.18%) 
Blood and lymphatic system disorders         
Anaemia  0/191 (0.00%)  2/189 (1.06%)  2/382 (0.52%)  3/383 (0.78%) 
Thrombocytopenia  2/191 (1.05%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Anaemia Haemolytic Autoimmune  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Pancytopenia  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Cardiac disorders         
Angina Pectoris  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  2/383 (0.52%) 
Acute Coronary Syndrome  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Arrhythmia  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Atrial Fibrillation  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Cardiac Arrest  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Cardiac Failure Congestive  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Myocardial Infarction  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Endocrine disorders         
Hyperthyroidism  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Eye disorders         
Retinal Haemorrhage  1/191 (0.52%)  1/189 (0.53%)  1/382 (0.26%)  0/383 (0.00%) 
Retinal Detachment  0/191 (0.00%)  1/189 (0.53%)  1/382 (0.26%)  0/383 (0.00%) 
Glaucoma  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  2/383 (0.52%) 
Intestinal Obstruction  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Pancreatitis Acute  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Small Intestinal Obstruction  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Vomiting  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
General disorders         
Non-Cardiac Chest Pain  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Asthenia  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Fatigue  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Gait Disturbance  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Hyperplasia  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Malaise  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Multi-Organ Failure  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Pain  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Hepatobiliary disorders         
Cholelithiasis  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  1/383 (0.26%) 
Hepatic Failure  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  1/383 (0.26%) 
Cholecystitis  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Cholecystitis Acute  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Hepatorenal Syndrome  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Infections and infestations         
Pneumonia  1/191 (0.52%)  3/189 (1.59%)  2/382 (0.52%)  4/383 (1.04%) 
Appendicitis  0/191 (0.00%)  0/189 (0.00%)  3/382 (0.79%)  2/383 (0.52%) 
Cellulitis  1/191 (0.52%)  0/189 (0.00%)  2/382 (0.52%)  0/383 (0.00%) 
Abscess Limb  1/191 (0.52%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Gastroenteritis  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  1/383 (0.26%) 
Pyelonephritis  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  1/383 (0.26%) 
Pyelonephritis Acute  0/191 (0.00%)  2/189 (1.06%)  0/382 (0.00%)  0/383 (0.00%) 
Anal Abscess  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Bronchitis  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Bursitis Infective  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Gastroenteritis Viral  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Injection Site Abscess  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Intervertebral Discitis  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Lobar Pneumonia  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Lung Abscess  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Lung Infection  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Osteomyelitis  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Pelvic Abscess  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Pelvic Inflammatory Disease  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Rectal Abscess  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Sepsis  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Subcutaneous Abscess  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Injury, poisoning and procedural complications         
Overdose  0/191 (0.00%)  1/189 (0.53%)  1/382 (0.26%)  0/383 (0.00%) 
Ankle Fracture  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Meniscus Lesion  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Multiple Fractures  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Postoperative Fever  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Radius Fracture  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Venom Poisoning  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Metabolism and nutrition disorders         
Dehydration  0/191 (0.00%)  0/189 (0.00%)  2/382 (0.52%)  1/383 (0.26%) 
Diabetic Ketoacidosis  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Musculoskeletal and connective tissue disorders         
Back Pain  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Fracture Nonunion  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Intervertebral Disc Protrusion  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Musculoskeletal Chest Pain  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Hepatic Neoplasm Malignant  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Pancreatic Carcinoma  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Pancreatic Neoplasm  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Tonsil Cancer  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Nervous system disorders         
Cerebral Haemorrhage  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  1/383 (0.26%) 
Altered State of Consciousness  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Cerebrovascular Accident  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Headache  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Hepatic Encephalopathy  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Metabolic Encephalopathy  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Peripheral Motor Neuropathy  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Syncope  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Transient Ischaemic Attack  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Psychiatric disorders         
Depression  0/191 (0.00%)  3/189 (1.59%)  1/382 (0.26%)  0/383 (0.00%) 
Suicidal Ideation  0/191 (0.00%)  0/189 (0.00%)  2/382 (0.52%)  0/383 (0.00%) 
Acute Psychosis  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Alcoholism  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Bipolar Disorder  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Completed Suicide  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Dependence  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Hostility  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Major Depression  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Panic Attack  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  0/383 (0.00%) 
Psychotic Disorder  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Suicide Attempt  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Renal and urinary disorders         
Calculus Ureteric  0/191 (0.00%)  0/189 (0.00%)  2/382 (0.52%)  0/383 (0.00%) 
Renal Failure Acute  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Tubulointerstitial Nephritis  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Respiratory, thoracic and mediastinal disorders         
Alveolitis Fibrosing  1/191 (0.52%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Haemoptysis  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  2/383 (0.52%) 
Pneumothorax  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Psoriasis  0/191 (0.00%)  0/189 (0.00%)  1/382 (0.26%)  0/383 (0.00%) 
Skin Ulcer  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Vascular disorders         
Hypertension  0/191 (0.00%)  0/189 (0.00%)  0/382 (0.00%)  1/383 (0.26%) 
Vena Cava Thrombosis  0/191 (0.00%)  1/189 (0.53%)  0/382 (0.00%)  0/383 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg PEG-IFN 360/180 µg + Ribavirin 1200 mg PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   186/191 (97.38%)   179/189 (94.71%)   370/382 (96.86%)   373/383 (97.39%) 
Blood and lymphatic system disorders         
Anaemia  23/191 (12.04%)  22/189 (11.64%)  38/382 (9.95%)  54/383 (14.10%) 
Neutropenia  9/191 (4.71%)  16/189 (8.47%)  29/382 (7.59%)  28/383 (7.31%) 
Gastrointestinal disorders         
Nausea  41/191 (21.47%)  42/189 (22.22%)  112/382 (29.32%)  104/383 (27.15%) 
Diarrhoea  25/191 (13.09%)  27/189 (14.29%)  62/382 (16.23%)  62/383 (16.19%) 
Vomiting  12/191 (6.28%)  19/189 (10.05%)  42/382 (10.99%)  31/383 (8.09%) 
Abdominal Pain Upper  11/191 (5.76%)  18/189 (9.52%)  28/382 (7.33%)  23/383 (6.01%) 
Dyspepsia  9/191 (4.71%)  12/189 (6.35%)  25/382 (6.54%)  23/383 (6.01%) 
Dry Mouth  5/191 (2.62%)  14/189 (7.41%)  23/382 (6.02%)  23/383 (6.01%) 
Abdominal Pain  6/191 (3.14%)  10/189 (5.29%)  15/382 (3.93%)  13/383 (3.39%) 
Constipation  5/191 (2.62%)  13/189 (6.88%)  9/382 (2.36%)  14/383 (3.66%) 
General disorders         
Pyrexia  83/191 (43.46%)  78/189 (41.27%)  176/382 (46.07%)  205/383 (53.52%) 
Fatigue  66/191 (34.55%)  102/189 (53.97%)  184/382 (48.17%)  182/383 (47.52%) 
Chills  42/191 (21.99%)  55/189 (29.10%)  122/382 (31.94%)  132/383 (34.46%) 
Asthenia  28/191 (14.66%)  35/189 (18.52%)  84/382 (21.99%)  80/383 (20.89%) 
Irritability  34/191 (17.80%)  29/189 (15.34%)  64/382 (16.75%)  66/383 (17.23%) 
Pain  10/191 (5.24%)  18/189 (9.52%)  24/382 (6.28%)  31/383 (8.09%) 
Injection Site Erythema  16/191 (8.38%)  14/189 (7.41%)  28/382 (7.33%)  24/383 (6.27%) 
Injection Site Reaction  12/191 (6.28%)  13/189 (6.88%)  20/382 (5.24%)  14/383 (3.66%) 
Malaise  10/191 (5.24%)  10/189 (5.29%)  14/382 (3.66%)  18/383 (4.70%) 
Infections and infestations         
Upper Respiratory Tract Infection  11/191 (5.76%)  7/189 (3.70%)  11/382 (2.88%)  16/383 (4.18%) 
Investigations         
Weight Decreased  31/191 (16.23%)  31/189 (16.40%)  54/382 (14.14%)  67/383 (17.49%) 
Metabolism and nutrition disorders         
Decreased Appetite  30/191 (15.71%)  31/189 (16.40%)  73/382 (19.11%)  85/383 (22.19%) 
Musculoskeletal and connective tissue disorders         
Myalgia  46/191 (24.08%)  44/189 (23.28%)  111/382 (29.06%)  118/383 (30.81%) 
Arthralgia  50/191 (26.18%)  49/189 (25.93%)  88/382 (23.04%)  89/383 (23.24%) 
Back Pain  21/191 (10.99%)  22/189 (11.64%)  28/382 (7.33%)  23/383 (6.01%) 
Muscle Spasms  8/191 (4.19%)  12/189 (6.35%)  13/382 (3.40%)  15/383 (3.92%) 
Nervous system disorders         
Headache  75/191 (39.27%)  76/189 (40.21%)  151/382 (39.53%)  168/383 (43.86%) 
Dizziness  14/191 (7.33%)  27/189 (14.29%)  44/382 (11.52%)  59/383 (15.40%) 
Disturbance in Attention  5/191 (2.62%)  6/189 (3.17%)  20/382 (5.24%)  27/383 (7.05%) 
Psychiatric disorders         
Insomnia  46/191 (24.08%)  45/189 (23.81%)  98/382 (25.65%)  113/383 (29.50%) 
Depression  31/191 (16.23%)  33/189 (17.46%)  65/382 (17.02%)  56/383 (14.62%) 
Anxiety  11/191 (5.76%)  18/189 (9.52%)  31/382 (8.12%)  23/383 (6.01%) 
Respiratory, thoracic and mediastinal disorders         
Cough  27/191 (14.14%)  35/189 (18.52%)  59/382 (15.45%)  69/383 (18.02%) 
Dyspnoea  15/191 (7.85%)  15/189 (7.94%)  39/382 (10.21%)  32/383 (8.36%) 
Oropharyngeal Pain  12/191 (6.28%)  11/189 (5.82%)  16/382 (4.19%)  22/383 (5.74%) 
Dyspnoea Exertional  6/191 (3.14%)  13/189 (6.88%)  17/382 (4.45%)  16/383 (4.18%) 
Epistaxis  10/191 (5.24%)  10/189 (5.29%)  9/382 (2.36%)  14/383 (3.66%) 
Skin and subcutaneous tissue disorders         
Rash  38/191 (19.90%)  40/189 (21.16%)  65/382 (17.02%)  78/383 (20.37%) 
Pruritus  34/191 (17.80%)  27/189 (14.29%)  76/382 (19.90%)  59/383 (15.40%) 
Alopecia  23/191 (12.04%)  20/189 (10.58%)  71/382 (18.59%)  71/383 (18.54%) 
Dry Skin  23/191 (12.04%)  22/189 (11.64%)  38/382 (9.95%)  37/383 (9.66%) 
Vascular disorders         
Hypertension  7/191 (3.66%)  11/189 (5.82%)  16/382 (4.19%)  20/383 (5.22%) 
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: Hoffmann-La Roche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00394277     History of Changes
Other Study ID Numbers: NV18210
First Submitted: October 30, 2006
First Posted: October 31, 2006
Results First Submitted: May 27, 2010
Results First Posted: July 5, 2010
Last Update Posted: August 3, 2010