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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:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01254994
First received: December 6, 2010
Last updated: NA
Last verified: August 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Lin Bingliang, Third Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01254994     History of Changes
Other Study ID Numbers: Entecavir
Study First Received: December 6, 2010
Last Updated: December 6, 2010
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014