Status:
COMPLETED
Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Collaborating Sponsors:
Peking University People's Hospital
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 dos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT01140997
Start Date
July 1 2010
End Date
March 1 2012
Last Update
February 4 2013
Active Locations (38)
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1
302 Military Hospital
Beijing, China
2
Beijing Youan Hospital, Capital Medical University
Beijing, China
3
Beijing Youyi Hospital, Capital Medical University
Beijing, China
4
Peking University First Hospital
Beijing, China