- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01254994
The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
December 6, 2010 updated by: Sun Yat-sen University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510630
- The Third Affiliated Hospital of Sun Yat-Sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
The patients were prescribed the tradition comprehensive medical treatment without entecavir.
|
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.
|
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptoms,signs and mortality
Time Frame: 48 weeks
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lin B Liang, MD, Third Affiliated Hospital, Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 6, 2010
First Submitted That Met QC Criteria
December 6, 2010
First Posted (Estimate)
December 7, 2010
Study Record Updates
Last Update Posted (Estimate)
December 7, 2010
Last Update Submitted That Met QC Criteria
December 6, 2010
Last Verified
August 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Hepatitis, Chronic
- Liver Failure
- Hepatic Insufficiency
- Hepatitis B
- Hepatitis
- Hepatitis B, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Entecavir
Other Study ID Numbers
- Entecavir
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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