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A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment

NCT05550519 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2025-06-25

No results posted yet for this study

Summary

The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (\<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (\>) 100 IU/mL to \<= 500 IU/mL at baseline.

Conditions

  • Hepatitis B, Chronic

Interventions

OTHER

Entecavir (ETV)

ETV will continue throughout screening and will be stopped at baseline.

OTHER

Tenofovir Disoproxil Fumarate (TDF)

TDF will continue throughout screening and will be stopped at baseline.

OTHER

Tenofovir Alafenamide (TAF)

TAF will continue throughout screening and will be stopped at baseline.

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutica N.V., Belgium Clinical Trial · Janssen Pharmaceutica N.V., Belgium

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2025-08-25
Completion
2025-08-28

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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 NCT05550519 on ClinicalTrials.gov