RECRUITINGINTERVENTIONAL
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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.
Who Should NOT Join This Trial:
1. Other active liver diseases;
2. Hepatocellular carcinoma or other malignancy;
3. Pregnancy or lactation;
4. Human weakened immune system virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune conditions (where your immune system attacks your own body)s;
6. Other important organ dysfunctions;
7. Using glucocorticoid;
8. Patients can not follow-up;
9. Investigator considering inappropriate.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Entecavir
Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
DRUG
Tenofovir Disoproxil Fumarate
Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
DRUG
Tenofovir Alafenamide
Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
Locations (1)
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China