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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254994
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sun Yat-sen University
  Purpose
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.

Condition Intervention Phase
Liver Failure Drug: entecavir Drug: Traditional comprehensive medical treatment Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Symptoms,signs and mortality [ Time Frame: 48 weeks ]

Enrollment: 108
Study Start Date: August 2007
Study Completion Date: December 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control group
The patients were prescribed the tradition comprehensive medical treatment without entecavir.
Drug: 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.
Experimental: ETV group
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
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254994


Locations
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Lin B Liang, MD Third Affiliated Hospital, Sun Yat-Sen University
  More Information

Additional Information:
Responsible Party: Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01254994     History of Changes
Other Study ID Numbers: Entecavir
First Submitted: December 6, 2010
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
Last Verified: August 2007

Keywords provided by Sun Yat-sen University:
hepatitis B
acute on chronic liver failure (ACHBLF)
entecavir
treatment
predicting

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Failure
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatic Insufficiency
Entecavir
Antiviral Agents
Anti-Infective Agents