The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure
|ClinicalTrials.gov Identifier: NCT01254994|
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : December 7, 2010
|Condition or disease||Intervention/treatment||Phase|
|Liver Failure||Drug: entecavir Drug: Traditional comprehensive medical treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2007|
|Primary Completion Date :||July 2009|
|Study Completion Date :||December 2010|
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.
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
- 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)
- Symptoms,signs and mortality [ Time Frame: 48 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254994
|The Third Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510630|
|Principal Investigator:||Lin B Liang, MD||Third Affiliated Hospital, Sun Yat-Sen University|