Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
- Conditions
- Chronic Hepatitis B
- Interventions
- Registration Number
- NCT01143662
- 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 efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week 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 pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- Age:18~60 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.
- Serum HBsAg positive for at least 6 months.
- Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
- 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
- Pregnant or lactating women.
- Mental disorder or physical disability.
- Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
- WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
- Co-infection with HAV, HIV, HCV, HDV, HEV.
- Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
- Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- Evidence of hepatic decompensation.
- History of hypothyroidism or current treatment for thyroid disease.
- Uncontrolled significant chronic medical conditions other than chronic hepatitis B, 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 Group 2 Ypeginterferon alfa-2b Ypeginterferon alfa-2b 135mcg per week Group 3 Ypeginterferon alfa-2b Ypeginterferon alfa-2b 180mcg per week Group 4 Peginterferon alfa-2a Pegasys 180mcg per week
- Primary Outcome Measures
Name Time Method Efficacy week 24 from treatment start * Average of HBV DAN decline level at week 24.
* Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
- Secondary Outcome Measures
Name Time Method Efficacy week 12, 24, 48 from treatment start and week 24 after treatment * Average of HBV DNA decline level at week 12, 48 and 72.
* Proportion of patients with HBV DNA undetectable at week 48 and 72.
* Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72.
* Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72.
* Proportion of patients with ALT normalization at week 24 and 48.
Trial Locations
- Locations (39)
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
Southwest Hospital
🇨🇳Chongqing, China
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