A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

Study Overview
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Brief Summary
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This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.

Official Title
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An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR

Conditions
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Hepatitis C, Chronic

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients >/= 18 years of age Chronic hepatitis C, genotype 1, 2, 3 Compensated liver disease Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders Exclusion Criteria: Decompensated liver disease Signs or symptoms of hepatocellular carcinoma Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Drug: COPEGUS<br>* COPEGUS 800 mg or 1000-1200 mg po for 24 weeks<br>Drug: peginterferon alfa-2a [Pegasys]<br>* PEGASYS 180 micrograms sc once weekly for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Treatment Response Rate at Week 72 in Genotype 1 | End of treatment response rate at Week 72 was reported for genotype 1. | Week 72 | 
| End of Treatment Response in Genotype 2 and 3 | End of treatment response rate at Week 48 was reported for genotype 2 and 3. | Week 48 | 
| Sustained Viral Response (SVR) Rates in CHC Genotype 1 | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1. | Week 96 | 
| SVR Rates in Genotype 2 and 3. | Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3. | Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Event (AE) | An AE is defined as 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. | Week 96 |