A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Official Title
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Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: peginterferon alfa-2a [Pegasys]
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients, >=18 years of age; serological evidence of chronic hepatitis C; detectable serum HCV-RNA; liver biopsy findings consistent with a diagnosis of chronic hepatitis C. Exclusion Criteria: history or other evidence of a medical condition associated with chronic liver disease other than HCV; co-infection with active hepatitis A or B; hepatocellular carcinoma; patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: peginterferon alfa-2a [Pegasys]<br>* 180micrograms sc weekly for 12-48 weeks<br>Drug: ribavirin<br>* 800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs. | From signing of informed consent up to end of study (up to Week 72) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy | SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy. | 24 weeks after end of therapy (Week 72) | 
| Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48. | Weeks 12,24 and 48 After Therapy Initiation | 
| Percentage of Participants With Change in Hemoglobin Level | Change in hemoglobin level (compared to baseline) was reported as significant decrease, Normal (no change), Increase, Decrease, and Missing. Significant decrease was defined as per Investigator's discretion. | Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) |