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A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

NCT04129554 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-02-04

Study results available
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Summary

The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

JNJ-73763989

JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.

DRUG

JNJ-56136379

JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.

DRUG

Placebo for JNJ-73763989

Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.

DRUG

Placebo for JNJ-56136379

Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.

DRUG

Entecavir (ETV) monohydrate

ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.

DRUG

Tenofovir disoproxil fumarate (TDF)

TDF will be administered orally once daily up to 48 weeks as NA treatment.

DRUG

Tenofovir alafenamide (TAF)

TAF will be administered orally once daily up to 48 weeks as NA treatment.

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-06
Primary Completion
2021-07-08
Completion
2022-06-09
FDA Drug
Yes

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

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 NCT04129554 on ClinicalTrials.gov