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The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure

NCT03640728 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-02-09

No results posted yet for this study

Summary

HBV-related acute-on-chronic liver failure (ACLF) is a clinical syndrome defined as acute hepatic insult with diagnosed or undiagnosed chronic liver disease. Current clinical guidelines advocate oral antiviral treatment in HBV-related ACLF. However, no conclusion on which nucleoside analogue is the most satisfactory drug for the treatment of HBV-related liver failure has not been reached yet. In this cohort study, the investigators will compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF), Tenofovir Disoproxil Fumarate (TDF) and entecavir (ETV) in HBV-related ACLF in China. In addition, the drug metabolism characteristics of TAF will be explored in such severe liver injury population of HBV-ACLF.

Conditions

Interventions

DRUG

Tenofovir Alafenamide

Tenofovir alafenamide 25 mg/day orally

DRUG

Entecavir

Entecavir 0.5 mg/day orally

DRUG

Tenofovir disoproxil fumarate

Tenofovir Disoproxil Fumarate 300 mg/day orally

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Yingli He, M.D.,Ph.D · First Affiliated Hospital Xi'an Jiaotong University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2021-04-30
Completion
2023-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640728 on ClinicalTrials.gov