Status:
UNKNOWN
Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B
Lead Sponsor:
Beijing 302 Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
16-60 years
Phase:
PHASE4
Brief Summary
Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and five nucleons(t)ide analogues. The current treatment strategy of chronic hepatitis B is n...
Eligibility Criteria
Inclusion
- Age≥16 years
- HBsAg positive for more than 6 months, and HBeAg detection is positive for two times in 6 months before enrollment
- Serum HBVDNA \>2×10\^4IU/ml
- 80U/L \< serum ALT \< 400U/L, and TBIL \< 34 umol/L
- Serum ALT \< 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S3
Exclusion
- Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
- Hepatic decompensation
- received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
- Blood routine examination: WBC \<3×10\^9/L，neutrophile granulocyte \< 1.5×10\^9/L，PLT \<80×10\^9/L
- Renal function: creatinine \>1.5 times of upper normal limit
- Alcoholism or a history of addiction and abuse
- Combined with hepatocarcinoma
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01906580
Start Date
July 1 2011
End Date
July 1 2016
Last Update
August 17 2015
Active Locations (1)
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1
Research Center for Biological Therapy, The Institute of Translational Hepatology, Beijing 302 Hospital
Beijing, China, 100039