Clinical trial NCT01581398: Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
Official title: A Phase 3, Randomized, Multi-center, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Combination With Ribavirin in Chinese Chronic Hepatitis C Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Peginterferon
Pegasys
Sustained virus response
HCV
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Proportion of patients with sustained virologic response (defined as HCV RNA<15IU/ml at 24 weeks after the end of therapy)
timeFrame: 24 weeks after the end of therapy
Secondary outcomes:
measure: Proportion of patients with HCV RNA undetectable (defined as HCV RNA <15IU/ml)
timeFrame: at weeks 4, 12, 24 for genotype 2/3, and weeks 4, 12, 24 and 48 for non-genotype 2/3
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital
city: Beijing
country: China
facility: Beijing Youan Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Youyi Hospital, capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changchun
country: China
facility: First Affiliated Hospital of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital, Central-south University
city: Changsha
country: China
facility: Xiangya Second Hospital, Central-south University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Chongqing
country: China
facility: Second Affiliated Hospital Chongqing Medical University
city: Chongqing
country: China
facility: Southwest Hospital
city: Fuzhou
country: China
facility: Fuzhou Infectious Disease Hospital
city: Guangzhou
country: China
facility: Guangzhou Eighth People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
city: Guilin
country: China
facility: First Affiliated Hospital of Guangxi Medical University
city: Guiyang
country: China
facility: Affiliated Hospital of Guiyang Medical College
city: Hangzhou
country: China
facility: First Affiliated Hospital, Zhejiang University
city: Harbin
country: China
facility: Second Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
city: Jinan
country: China
facility: Jinan Infectious Disease Hospital
city: Lanzhou
country: China
facility: First Affiliated Hospital of Lanzhou University
city: Nanchang
country: China
facility: First Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: 81 Military Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Second Hospital of Nanjing
city: Shanghai
country: China
facility: 85 Militay Hospital
city: Shanghai
country: China
facility: Huashan Hospital
city: Shanghai
country: China
facility: Renji Hospital
city: Shanghai
country: China
facility: Ruijing Hospital
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shijiazhuang
country: China
facility: Third Affiliated Hospital, Hebei Medical University
city: Taiyuan
country: China
facility: First Affiliated Hospital, Shanxi University
city: Tianjin
country: China
facility: Tianjin Third Central Hospital
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Wulumuqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xian
country: China
facility: Tangdu Hospital, Fourth Military Medical University
city: Xian
country: China
facility: Xijing Hospital
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Hennan Provincial People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Wei Lai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: