The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
NCT ID: NCT01254994
Last Updated: 2010-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2007-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
The patients were prescribed the tradition comprehensive medical treatment without entecavir.
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.
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.
entecavir
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
Interventions
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entecavir
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
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.
Eligibility Criteria
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Inclusion Criteria
* age \>18 years
* HBV DNA \> 3log10 copy/mL
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Third Affiliated Hospital, Sun Yat-sen University
Principal Investigators
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Lin B Liang, MD
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Related Links
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The Third Affiliated Hospital of Sun Yat-sen University
Other Identifiers
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Entecavir
Identifier Type: -
Identifier Source: org_study_id