Status:
COMPLETED
The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
Lead Sponsor:
Sun Yat-sen University
Conditions:
Liver Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated ...
Eligibility Criteria
Inclusion
- ACHBLF was diagnosed according to the criteria from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September 2000.
- age \>18 years
- HBV DNA \> 3log10 copy/mL
Exclusion
- Pregnant or lactating women.
- Diagnosed or suspected as hepatic carcinoma patients.
- Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc.
- Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment.
- A history of drug abuse or alcohol abuse.
- Hepatic encephalopathy degree IV patients who were unable to take orally administered drugs.
- A history of using immunomodulator including steroids
- Conclusive evidence of other co infection s: anti-HAV-IgM positive, anti-HCV positive, anti-HEV positive, anti-HIV positive, autoimmunity liver diseases, Wilson disease, etc.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01254994
Start Date
August 1 2007
End Date
December 1 2010
Last Update
December 7 2010
Active Locations (1)
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1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630