Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
- Registration Number
- NCT01760122
- Lead Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Brief Summary
This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 820
- Age: 18~65 years.
- Serum HBsAg or HBV DNA positive for at least 6 months.
- Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
- 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
- Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.
- 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.
- ANC < 1500/mm3, or PLT < 90,000/mm3.
- Co-infection with HAV, HIV, HCV, HDV, or HEV.
- Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
- Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L).
- Chronic hepatitis caused by any other reason except hepatitis B.
- Hepatocarcinoma or suffering from any other malignant tumor.
- Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
- Significant function damage in any major organs (e.g.: heart, lung, kidney).
- Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ypeginterferon Alfa-2b Ypeginterferon alfa-2b - Pegasys Pegasys -
- Primary Outcome Measures
Name Time Method Proportion of patients with HBeAg seroconversion at week72 24 weeks after the cessation of treatment
- Secondary Outcome Measures
Name Time Method Proportion of patients with ALT normalization at week 12,24, 48 and 72. week 12, 24, 48 and 72 from treatment starting Average of HBV DNA decline level at week 12, 24,48 and 72 week 12, 24, 48 and 72 from treatment starting Proportion of Patients with HBeAg seroconversion at week 12,24,48 week 12, 24, 48 from treatment starting Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72. week 4, 12, 24, 48 and 72 from treatment starting Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72. week 12, 24, 48 and 72 from treatment starting
Trial Locations
- Locations (43)
Beijing Youan Hospital, Capital Medical University
🇨🇳Beijing, China
Xiangya Hospital, Central-south University
🇨🇳Changsha, China
Xiangya Second Hospital, Central-south University
🇨🇳Changsha, China
Fuzhou Infectious Disease Hospital
🇨🇳Fuzhou, China
Guangzhou Eighth People's Hospital
🇨🇳Guangzhou, China
Beijing Youyi Hospital, Capital Medical University
🇨🇳Beijing, China
Xiamen Hospital of T.C.M
🇨🇳Xiamen, Fujian, China
Beijing University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
302 Military Hospital
🇨🇳Beijing, China
Beijing Ditan Hospital Capital Medical University
🇨🇳Beijing, China
First Affiliated Hospital of Jilin University
🇨🇳Changchun, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Second Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, China
Peking University People's Hospital
🇨🇳Beijing, China
Southwest Hospital
🇨🇳Chongqing, China
Nanfang Hospital
🇨🇳Guangzhou, China
First Affiliated Hospital of Guangxi Medical University
🇨🇳Guilin, China
First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, China
Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, China
Jinan Infectious Disease Hospital
🇨🇳Jinan, China
First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, China
81 Military Hospital
🇨🇳Nanchang, China
First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
85 Military Hospital
🇨🇳Shanghai, China
Huashan Hospital
🇨🇳Shanghai, China
Ruijing Hospital
🇨🇳Shanghai, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
Shenyang Sixed People's Hospital
🇨🇳Shenyang, China
Third Affiliated Hospital, Hebei Medical University
🇨🇳Shijiazhuang, China
First Affiliated Hospital, Shanxi University
🇨🇳Taiyuan, China
Tianjin Third Central Hospital
🇨🇳Tianjin, China
First Affiliated Hospital of Wenzhou Medical College
🇨🇳Wenzhou, China
Tongji Hospital, Huazhong University of Science & Technology
🇨🇳Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Wulumuqi, China
Tangdu Hospital, Fourth Military Medical University
🇨🇳Xi'an, China
Xijing Hospital
🇨🇳Xi'an, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
Second Hospital of Nanjing
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China