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Finite Versus Continuous Nucleos(t)Ide Analogues for Chronic Hepatitis B

NCT05793268 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2023-03-31

No results posted yet for this study

Summary

BACKGROUND:

Finite nucleos(t)ide analogue (Nuc) therapy was proposed as an alternative strategy in the management of chronic hepatitis B (CHB) but there remained not data from randomized controlled trials to clarify safety and efficacy of this treatment strategy.

AIMS:

The investigators aimed to evaluate the safety and efficacy of finite Nuc therapy versus continuous treatment in CHB patients without liver cirrhosis and also to identify factors that may predict therapeutic responses and clinical outcomes after withdrawal of Nuc treatment for CHB

MATERIAL AND METHODS:

This is a multicenter randomized controlled trial conducted in Taiwan. Eligible patients are adults (age≥20 years) with CHB (chronic infection ≥ 6 months) who fulfill the APASL guideline 2016 to stop NA therapy. Those with cirrhosis, malignancy, organ transplant, autoimmune disorder, or serious underlying diseases including renal impairment were excluded. A total of 360 patients will be enrolled. Enrolled patients are randomly allocated with a 1:1 ratio to continue viral suppression with entecavir (0.5mg once daily) or tenofovir disoproxil fumarate (300mg once daily) or stop the treatment. All patients will be followed up according to the protocol recommended by a panel of APASL experts. The primary analysis for study outcomes is scheduled at 3 years after randomization and the primary outcome is seroclearance of HBsAg. There will be interim analyses scheduled at one- and two-years following randomization of the first 200 patients, and also one-and two years following randomization of the planned 360 patients, to determine whether early termination of the trial may be justified by attainment of the efficacy endpoint (10% vs 1% of HBsAg seroclearance) or concerns of the safety outcomes (significant between-group difference in mortality, acute on chronic liver failure, or acute flares with hepatic decompensation).

Conditions

Interventions

OTHER

Nuc Discontinuation

Eligible patients are randomly allocated with a 1:1 ratio to continue viral suppression or stop the treatment (entecavir or tenofovir). Patients will be followed up for 3 years. For patients who are assigned to the finite Nuc therapy, they should be monitored monthly for the initial 3 months and then every 3-6 months thereafter for relapse.

DRUG

Entecavir or Tenofovir

Continuation of either entecavir or tenofovir treatment for 3 years

Sponsors & Collaborators

  • E-DA Hospital

    lead OTHER

Principal Investigators

  • Yao-Chun Hsu, MD, PhD · E-Da Hospital/I-Shou University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-20
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT05793268 on ClinicalTrials.gov