Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01140997
- Lead Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Ypeginterferon alfa-2b Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d Group 2 Ypeginterferon alfa-2b Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d Group 4 Peginterferon alfa-2a Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d Group 3 Ypeginterferon alfa-2b Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
- Primary Outcome Measures
Name Time Method Efficacy week 12 Proportion of patients with HCV RNA undetectable at week 12.
- Secondary Outcome Measures
Name Time Method Efficacy Week 4, 12, 24, 48 and 72 1. Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72;
2. Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.
Trial Locations
- Locations (38)
302 Military Hospital
🇨🇳Beijing, China
Beijing Youan Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Youyi Hospital, Capital Medical University
🇨🇳Beijing, China
Peking University First Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
First Affiliated Hospital of Jilin University
🇨🇳Changchun, China
Xiangya Hospital, Central-south University
🇨🇳Changsha, China
Xiangya Second Hospital, Central-south University
🇨🇳Changsha, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Second Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, China
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