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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01254994
Other study ID # Entecavir
Secondary ID
Status Completed
Phase Phase 2
First received December 6, 2010
Last updated December 6, 2010
Start date August 2007
Est. completion date December 2010

Study information

Verified date August 2007
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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 into either a treatment group (ETV group, n=53) or a control group (n=55). The HBV DNA level, liver function and survival condition of the patients were observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment efficacy were also identified.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 2010
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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.

Study Design

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


Intervention

Drug:
entecavir
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
Traditional comprehensive medical treatment
bed rest, sufficient energy and vitamins, reduced glutathione, prostaglandin E1, hepatocyte growth factor (HGF), plasma and albumin, maintenance of water and electrolyte balance, and prevention and treatment of complications, such as infections, hepatic encephalopathy, hemorrhage, hepatorenal syndrome and ascites.

Locations

Country Name City State
China The Third Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary HBV DNA level and liver function HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio (INR), cholesterol (CHOL) 48 weeks Yes
Secondary Symptoms,signs and mortality 48 weeks Yes
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