SYREN Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin) in Non-Responder Patients With Chronic Hepatitis C (CHC) Genotype 1.

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
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Antiviral Effect of 4 Regimens of PEGASYS Plus Copegus in Patients With Genotype 1 Chronic Hepatitis C Non-responder to Previous Peginterferon Alfa-2a Plus Ribavirin Therapy

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Copegus
* Drug: Copegus
* Drug: peginterferon alfa-2a [Pegasys]
* 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, with CHC genotype 1; patients who have failed to respond to previous treatment with PEGASYS plus ribavirin for >=12 weeks; patients who have discontinued PEGASYS/ribavirin >=4 weeks prior to enrollment; compensated liver disease. Exclusion Criteria: other forms of liver disease; infection with HIV, HAV, HBV; hepatocellular cancer.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Copegus<br>* 1000-1200mg/day po<br>Drug: peginterferon alfa-2a [Pegasys]<br>* 360 micrograms sc weekly<br>|
| Experimental: 2<br> | Drug: Copegus<br>* 1000-1200mg/day po<br>Drug: peginterferon alfa-2a [Pegasys]<br>* 180 micrograms sc twice weekly<br>|
| Experimental: 3<br> | Drug: Copegus<br>* 1200-1600mg/day po<br>Drug: peginterferon alfa-2a [Pegasys]<br>* 360 micrograms sc weekly<br>|
| Experimental: 4<br> | Drug: Copegus<br>* 1200-1600mg/day po<br>Drug: peginterferon alfa-2a [Pegasys]<br>* 180 micrograms sc twice weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained viral response |  | Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with >=2log drop of HCV-RNA |  | Week 4, 12, 24. | 
| Percentage of patients with non-detectable HCV-RNA |  | Week 48 | 
| Relapse rate |  | Throughout study. |