Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Ypeginterferon alfa-2b; Drug: Peginterferon alfa-2a

• Registration Number: NCT01140997
• 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Study Start: 2010-07
• Primary Completion: 2011-01
• Study Completion: 2012-03
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Ypeginterferon alfa-2b	Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Group 2	Ypeginterferon alfa-2b	Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Group 4	Peginterferon alfa-2a	Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Group 3	Ypeginterferon alfa-2b	Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d

Primary Outcome Measures

Name	Time	Method
Efficacy	week 12	Proportion of patients with HCV RNA undetectable at week 12.

Secondary Outcome Measures

Name	Time	Method
Efficacy	Week 4, 12, 24, 48 and 72	1. Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72; 2. Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.

Trial Locations

Locations (38)

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

Southwest Hospital; 🇨🇳 Chongqing, China

First Affiliated Hospital of Guangxi Medical Universtiy; 🇨🇳 Guilin, China

First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, China

Jinan Infectious Disease Hospital; 🇨🇳 Jinan, China

First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

Changhai Hospital; 🇨🇳 Shanghai, China

Huashan Hospital; 🇨🇳 Shanghai, China

Renji Hospital; 🇨🇳 Shanghai, China

Ruijin Hospital; 🇨🇳 Shanghai, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, China

Shenzhen Third People's Hospital; 🇨🇳 Shenzhen, China

Third Affiliated Hospital, Hebei Medical University; 🇨🇳 Shijiazhuang, China

First Affiliated Hospital, Shanxi University; 🇨🇳 Taiyuan, China

First Affiliated Hospital of Wenzhou Medical College; 🇨🇳 Wenzhou, China

Tongji Hospital, Huazhong University of Science&Technology; 🇨🇳 Wuhan, China

Tangdu Hospital, Fouth Military Medical University; 🇨🇳 Xian, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, China

Beijing Youan Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beijing Youyi Hospital, Capital Medical University; 🇨🇳 Beijing, China

Second Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, China

First Affiliated Hospital of Lanzhou University; 🇨🇳 Lanzhou, China

85 Military Hospital; 🇨🇳 Shanghai, China

Guangzhou Eighth People's Hospital; 🇨🇳 Guangzhou, China

Nangfang Hospital; 🇨🇳 Guangzhou, China

81 Military Hospital; 🇨🇳 Nanjing, China

Tianjin Third Central Hospital; 🇨🇳 Tianjin, China

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, China

First Affiliated Hospital of Jilin University; 🇨🇳 Changchun, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

Xiangya Hospital, Central-south University; 🇨🇳 Changsha, China

Fuzhou Infectious Disease Hospital; 🇨🇳 Fuzhou, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, China

Second Hospital of Nanjing; 🇨🇳 Nanjing, China

Peking University First Hospital; 🇨🇳 Beijing, China