Status:
COMPLETED
Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Collaborating Sponsors:
Peking University First Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135m...
Eligibility Criteria
Inclusion
- Age:18\~60 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.
- Serum HBsAg positive for at least 6 months.
- Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
- 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
Exclusion
- Pregnant or lactating women.
- Mental disorder or physical disability.
- Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
- WBC\<3000/mm3, or ANC \<1500/mm3, or PLT \<90,000/mm3.
- Co-infection with HAV, HIV, HCV, HDV, HEV.
- Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
- Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- Evidence of hepatic decompensation.
- History of hypothyroidism or current treatment for thyroid disease.
- Uncontrolled significant chronic medical conditions other than chronic hepatitis B, 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 :
April 1 2012
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01143662
Start Date
July 1 2010
End Date
April 1 2012
Last Update
February 4 2013
Active Locations (39)
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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