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

Chronic Hepatitis C Clinical Trial

— PEGIFN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140997
• Other study ID #: TB1006IFN
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2010
• Last updated: January 31, 2013
• Start date: July 2010
• Est. completion date: March 2012

Study information

• Verified date: June 2010
• Source: Xiamen Amoytop Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: March 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
• Peginterferon alfa-2a
sc, qw, for 48 weeks.

Locations

Country	Name	City	State
China	302 Military Hospital	Beijing
China	Beijing Youan Hospital, Capital Medical University	Beijing
China	Beijing Youyi Hospital, Capital Medical University	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	First Affiliated Hospital of Jilin University	Changchun
China	Xiangya Hospital, Central-south University	Changsha
China	Xiangya Second Hospital, Central-south University	Changsha
China	West China Hospital, Sichuan University	Chengdu
China	Second Affiliated Hospital Chongqing Medical University	Chongqing
China	Southwest Hospital	Chongqing
China	Fuzhou Infectious Disease Hospital	Fuzhou
China	Guangzhou Eighth People's Hospital	Guangzhou
China	Nangfang Hospital	Guangzhou
China	First Affiliated Hospital of Guangxi Medical Universtiy	Guilin
China	Second Affiliated Hospital of Harbin Medical University	Harbin
China	First Affiliated Hospital of Anhui Medical University	Hefei
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	Jiangsu Province Hospital	Nanjing
China	Second Hospital of Nanjing	Nanjing
China	85 Military Hospital	Shanghai
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	Tianjin Third Central Hospital	Tianjin
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	First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Henan Provincial People's Hospital	Zhengzhou

Sponsors (2)

Lead Sponsor	Collaborator
Xiamen Amoytop Biotech Co., Ltd.	Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Proportion of patients with HCV RNA undetectable at week 12.	week 12	Yes
Secondary	Efficacy	Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72; Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.	Week 4, 12, 24, 48 and 72	Yes