Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
- Registration Number
- NCT01581398
- Lead Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks after the end of therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 770
- 18~65 years
- Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
- HCV RNA≥2000IU/mL, anti-HCV positive at screening
- Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
- Signed informed consent
- Pregnant or lactating women
- Mental or psychology disorder
- ANC<1500/mm3, or PLT<90,000/mm3, or Hb<ULN(Upper limit of Normal)
- Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
- Co-infection with HIV, HAV, HBV, HEV
- Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil>2ULN, Alb<35g/L)
- Hepatocarcinoma or suffering from any other malignant tumor
- Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
- Significant function damage in any major organs (e.g: heart, lung, kidney)
- Involved in other investigation within the previous 3 months
- 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 A1(Genotype2/3) Ypeginterferon alfa-2b Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day A2(Genotype 2/3) Pegasys Pegasys 180μg/week, in combination with Ribavirin 800mg/day B1(Non-genotype 2/3) Ypeginterferon alfa-2b Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight B2(Non-genotype 2/3) Pegasys Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
- Primary Outcome Measures
Name Time Method Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy) 24 weeks after the end of therapy
- Secondary Outcome Measures
Name Time Method Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml) at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3
Trial Locations
- Locations (42)
85 Militay Hospital
🇨🇳Shanghai, China
Huashan Hospital
🇨🇳Shanghai, China
Xiangya Hospital, Central-south University
🇨🇳Changsha, China
Guangzhou Eighth People's Hospital
🇨🇳Guangzhou, China
First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, China
First Affiliated Hospital of Jilin University
🇨🇳Changchun, China
302 Military Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Xiangya Second Hospital, Central-south University
🇨🇳Changsha, China
Second Affiliated Hospital Chongqing Medical University
🇨🇳Chongqing, China
Fuzhou Infectious Disease Hospital
🇨🇳Fuzhou, 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
Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, China
Jinan Infectious Disease Hospital
🇨🇳Jinan, China
First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, China
First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
81 Military Hospital
🇨🇳Nanjing, China
Renji Hospital
🇨🇳Shanghai, China
Ruijing Hospital
🇨🇳Shanghai, China
Third Affiliated Hospital, Hebei Medical University
🇨🇳Shijiazhuang, China
First Affiliated Hospital, Shanxi University
🇨🇳Taiyuan, China
Tianjin Third Central Hospital
🇨🇳Tianjin, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Wulumuqi, China
Hennan Provincial People's Hospital
🇨🇳Zhengzhou, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Xijing Hospital
🇨🇳Xian, China
Beijing Youyi Hospital, capital Medical University
🇨🇳Beijing, China
Beijing Youan Hospital, Capital Medical University
🇨🇳Beijing, China
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Southwest Hospital
🇨🇳Chongqing, China
Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, China
Nanfang Hospital
🇨🇳Guangzhou, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, China
Tangdu Hospital, Fourth Military Medical University
🇨🇳Xian, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Jiangsu Province Hospital
🇨🇳Nanjing, China
Second Hospital of Nanjing
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China