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

NCT01254994 | Completed Phase 2 DMC

• 1 other identifier: Entecavir
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Failure

Keywords

hepatitis B; acute on chronic liver failure (ACHBLF); entecavir; treatment; predicting

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Symptoms,signs and mortality

  48 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

The patients were prescribed the tradition comprehensive medical treatment without entecavir.

Drug: Traditional comprehensive medical treatment

ETV group

EXPERIMENTAL

All the patients were prescribed the tradition comprehensive medical treatment with entecavir. Entecavir was supplied by the Sino-US Shanghai Squibb Pharmaceutical Co., Ltd. Patients took 0.5 mg entecavir following oral fasting one time per day.

Drug: entecavir

Interventions

entecavir DRUG

Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.

ETV group

Traditional comprehensive medical treatment DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Links

• The Third Affiliated Hospital of Sun Yat-sen University

MeSH Terms

Conditions

Liver Failure; Hepatitis B; Acute-On-Chronic Liver Failure

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Failure, Acute

Study Officials

• Lin B Liang, MD

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: August 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2010
• Last Updated: December 7, 2010

Record last verified: 2007-08

Locations

CN (1)