Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C

Study Overview
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Brief Summary
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This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.

Official Title
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A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Ypeginterferon alfa-2b
* Drug: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 65 years. Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment. Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C. HCV RNA≥2000IU/ml. Exclusion Criteria: Pregnant or lactating women. Mental disorder or physical disability. WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3. Received interferon treatment within the previous 6 months or shew no response to interferon. Co-infection with HIV, HAV, HBV, HEV. Evidence of hepatic decompensation. Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. History of hypothyroidism or current treatment for thyroid disease. Diabetes mellitus. Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.

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: Group 1<br>Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d | Drug: Ypeginterferon alfa-2b<br>* sc, qw, for 48 weeks.<br>* Other names: Peginterferon alfa-2b;|
| Experimental: Group 2<br>Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d | Drug: Ypeginterferon alfa-2b<br>* sc, qw, for 48 weeks.<br>* Other names: Peginterferon alfa-2b;|
| Experimental: Group 3<br>Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d | Drug: Ypeginterferon alfa-2b<br>* sc, qw, for 48 weeks.<br>* Other names: Peginterferon alfa-2b;|
| Active Comparator: Group 4<br>Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d | Drug: Peginterferon alfa-2a<br>* sc, qw, for 48 weeks.<br>* Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Proportion of patients with HCV RNA undetectable at week 12. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72; Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72. | Week 4, 12, 24, 48 and 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV, CHC, Hepatitis C, Chronic, Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepadnaviridae Infections, Antiviral Agents, Virus Diseases, Peginterferon alfa