Acute-On-Chronic Liver Failure, Hepatitis B
Conditions
Keywords
hepatitis b virus, acute-on-chronic liver failure, nucleotide, nucleoside
Brief summary
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.
Detailed description
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.
Interventions
DRUGEntecavir
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
DRUGTenofovir Disoproxil Fumarate
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
DRUGTenofovir Alafenamide
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year; 2. Age from 12 to 65 years old; 3. Serum total bilirubin level \> 10 times upper limit of normal; 4. Prothrombin time activity \< 40% or prothrombin time international ratio \> 1.5； 5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.
Exclusion criteria
1. Other active liver diseases; 2. Hepatocellular carcinoma or other malignancy; 3. Pregnancy or lactation; 4. Human immunodeficiency virus infection or congenital immune deficiency diseases; 5. Severe diabetes, autoimmune diseases; 6. Other important organ dysfunctions; 7. Using glucocorticoid; 8. Patients can not follow-up; 9. Investigator considering inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate in the follow-up | 144 week | Whether patients will survive after treatment is observed in the follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Model for end-stage liver disease (MELD) score is recorded after treatment | 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | 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. |
| Ratio of patients with undetectable hepatitis b virus DNA after treatment | 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week | 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. |
Countries
China
Contacts
Primary ContactWenxiong Xu, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed