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

Primary Purpose

Liver Failure

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
entecavir
Traditional comprehensive medical treatment
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Failure focused on measuring hepatitis B, acute on chronic liver failure (ACHBLF), entecavir, treatment, predicting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

ETV group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Symptoms,signs and mortality

Full Information

First Posted
December 6, 2010
Last Updated
December 6, 2010
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01254994
Brief Title
The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
Keywords
hepatitis B, acute on chronic liver failure (ACHBLF), entecavir, treatment, predicting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients were prescribed the tradition comprehensive medical treatment without entecavir.
Arm Title
ETV group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
entecavir
Intervention Description
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
Intervention Type
Drug
Intervention Name(s)
Traditional comprehensive medical treatment
Intervention Description
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 Outcome Measure Information:
Title
HBV DNA level and liver function
Description
HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL)
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Symptoms,signs and mortality
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin B Liang, MD
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.zssy.com.cn
Description
The Third Affiliated Hospital of Sun Yat-sen University

Learn more about this trial

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

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