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Completed

NCT Number: NCT01254994

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Entecavir

Drug

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

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.

Primary outcomes

  1. HBV DNA level and liver function

    Time frame: 48 weeks

    HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL)

Secondary outcomes

  1. Symptoms,signs and mortality

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Dec 7, 2010
Registry last updated
Dec 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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