Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF

Not Applicable

Recruiting

• Conditions: Hepatitis B; Acute-On-Chronic Liver Failure
• Interventions: Drug: Entecavir; Drug: Tenofovir Disoproxil Fumarate; Drug: Tenofovir Alafenamide

• Registration Number: NCT03920618
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2019-02-21
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETV group	Entecavir	50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
TDF group	Tenofovir Disoproxil Fumarate	50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
TAF group	Tenofovir Alafenamide	50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.

Primary Outcome Measures

Name	Time	Method
Survival rate in the follow-up	144 week	Whether patients will survive after treatment is observed in the follow-up.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China