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.
Overview
- Phase
- Phase 2
- Intervention
- Ypeginterferon alfa-2b
- Conditions
- Chronic Hepatitis C
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Enrollment
- 211
- Locations
- 38
- Primary Endpoint
- Efficacy
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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/mm
- •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.
Arms & Interventions
Group 1
Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Intervention: Ypeginterferon alfa-2b
Group 2
Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Intervention: Ypeginterferon alfa-2b
Group 3
Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
Intervention: Ypeginterferon alfa-2b
Group 4
Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Intervention: Peginterferon alfa-2a
Outcomes
Primary Outcomes
Efficacy
Time Frame: week 12
Proportion of patients with HCV RNA undetectable at week 12.
Secondary Outcomes
- Efficacy(Week 4, 12, 24, 48 and 72)