The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure

Liver Failure Clinical Trial

Official title:

A Prospective Open Label Control Study to Evaluate the Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254994
• Other study ID #: Entecavir
• 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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Failure

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

External Links

•   The Third Affiliated Hospital of Sun Yat-sen University