This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGSurvival rate in the follow-up
Whether patients will survive after treatment is observed in the follow-up.
Time frame: 144 week
Model for end-stage liver disease (MELD) score is recorded after treatment
The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln\[serum total bilirubin (mg/dl)\]+1.12ln(prothrombin time international normalized ratio)+0.95ln\[serum creatinin(mg/dl)\]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment.
Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
Ratio of patients with undetectable hepatitis b virus DNA after treatment
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment.
Time frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week
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