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Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels

NCT04780204 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-10-09

No results posted yet for this study

Summary

Multicenter, Open-label, Single arm Trial with Matched Historical controls. Male and female adults with compensated liver cirrhosis due to chronic hepatitis B virus infection who have low-level viremia.

To assess the efficacy of Tenofovir Alafenamide (TAF) in reducing liver-related events (hepatocellular carcinoma, liver-related events and death, decompensated liver cirrhosis) in cirrhotic chronic hepatitis B patients with low-level viremia compared with matched historical controls.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Treatment

Tenofovir Alafenamide 25 mg oral once daily

Sponsors & Collaborators

  • National Evidence-Based Healthcare Collaborating Agency

    collaborator OTHER_GOV

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Young-Suk Lim, PhD · Asan Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2027-01-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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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 NCT04780204 on ClinicalTrials.gov