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

ConditionsHepatitis BAcute-On-Chronic Liver Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-65
SponsorThird Affiliated Hospital, Sun Yat-Sen University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;

Age from 12 to 65 years old;

Serum total bilirubin level > 10 times upper limit of normal;

Prothrombin time activity < 40% or prothrombin time international ratio > 1.5；

Disqualifiers

Other active liver diseases;

Hepatocellular carcinoma or other malignancy;

Pregnancy or lactation;

Human immunodeficiency virus infection or congenital immune deficiency diseases;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Entecavir

    Drug

    Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.

  • Tenofovir Disoproxil Fumarate

    Drug

    Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.

  • Tenofovir Alafenamide

    Drug

    Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: ETV groupActive comparator 1 intervention
Group B: TDF groupActive comparator 1 intervention
Group C: TAF groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival rate in the follow-up

Whether patients will survive after treatment is observed in the follow-up.

Time frame
144 week

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov
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