Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.

Official Title
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A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Ypeginterferon alfa-2b
* Drug: Pegasys
* Drug: Ypeginterferon alfa-2b
* Drug: Pegasys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 65 years Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection HCV RNA≥2000IU/mL, anti-HCV positive at screening Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period Signed informed consent Exclusion Criteria: Pregnant or lactating women Mental or psychology disorder ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal) Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment Co-infection with HIV, HAV, HBV, HEV Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L) Hepatocarcinoma or suffering from any other malignant tumor Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus) Significant function damage in any major organs (e.g: heart, lung, kidney) Involved in other investigation within the previous 3 months Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: A1(Genotype2/3)<br>Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day | Drug: Ypeginterferon alfa-2b<br>* sc, qw, 24 weeks.<br>|
| Active Comparator: A2(Genotype 2/3)<br>Pegasys 180μg/week, in combination with Ribavirin 800mg/day | Drug: Pegasys<br>* sc, qw, 24 weeks.<br>|
| Experimental: B1(Non-genotype 2/3)<br>Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight | Drug: Ypeginterferon alfa-2b<br>* sc, qw, 48 weeks.<br>|
| Active Comparator: B2(Non-genotype 2/3)<br>Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight. | Drug: Pegasys<br>* sc, qw, 48 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy) |  | 24 weeks after the end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml) |  | at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peginterferon, Pegasys, Sustained virus response, HCV