Liver Failure
Conditions
Keywords
hepatitis B, acute on chronic liver failure (ACHBLF), entecavir, treatment, predicting
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.
Interventions
DRUGentecavir
Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
DRUGTraditional 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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HBV DNA level and liver function | 48 weeks | HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL) |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms,signs and mortality | 48 weeks |
Countries
China
Outcome results
None listed