A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)

Study Overview
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Brief Summary
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This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.

Official Title
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Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)

Conditions
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Hepatitis C, Chronic

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients, >/= 18 years of age Chronic hepatitis C Measurable serum HVC RNA levels Compensated liver disease (Child-Pugh class A) Treatment-naive for standard or pegylated interferons, or non-responder or relapsing Exclusion Criteria: Concomitant hepatitis A or B History of chronic liver disease not caused by hepatitis C virus Hepatocellular carcinoma History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug Pregnant or lactating women, or men whose partners are pregnant

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>genotype 1, treatment-naive | Drug: peginterferon alfa-2a [Pegasys]<br>* 180 mcg sc weekly<br>Drug: ribavirin [Copegus]<br>* 1'000/1'200 mg daily orally, 24 - 72 weeks<br>|
| Experimental: B<br>genotype 2 and 3, treatment-naive | Drug: peginterferon alfa-2a [Pegasys]<br>* 180 mcg sc weekly<br>Drug: ribavirin [Copegus]<br>* 800 mg daily orally, 16 - 48 weeks<br>|
| Experimental: C<br>all genotypes, non-responders or relapses | Drug: peginterferon alfa-2a [Pegasys]<br>* 180 mcg sc weekly<br>Drug: ribavirin [Copegus]<br>* 1'000/1'200 mg daily orally, 24 - 72 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of individualized Copegus treatment in combination with Pegasys: Adverse events |  | up to 96 weeks | 
| Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA) |  | up to 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virological response/sustained virological response (serum HCV RNA levels) |  | 24 weeks after treatment completion |