Clinical trial NCT01140997: Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
Official title: A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: HCV
CHC
Hepatitis C, Chronic
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepadnaviridae Infections
Antiviral Agents
Virus Diseases
Peginterferon alfa
Lead sponsor: Xiamen Amoytop Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Peking University People's Hospital
First posted: 2010-06-10
Enrollment: 211
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Efficacy
timeFrame: week 12
Secondary outcomes:
measure: Efficacy
timeFrame: Week 4, 12, 24, 48 and 72
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: Nangfang Hospital
city: Guilin
country: China
facility: First Affiliated Hospital of Guangxi Medical Universtiy
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 Military Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Huashan Hospital
city: Shanghai
country: China
facility: Renji Hospital
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
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: Wenzhou
country: China
facility: First Affiliated Hospital of Wenzhou Medical College
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science&Technology
city: Xian
country: China
facility: Tangdu Hospital, Fouth Military Medical University
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Wei Lai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feng B, Yang RF, Xie Q, Shang J, Kong FY, Zhang HY, Rao HY, Jin Q, Cong X, Liu YY, Kang Y, Wei L. Hepatitis C virus core antigen, an earlier and stronger predictor on sustained virological response in patients with genotype 1 HCV infection. BMC Gastroenterol. 2014 Mar 13;14:47. doi: 10.1186/1471-230X-14-47.