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A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

NCT03982186 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2025-02-04

Study results available
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Summary

The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

JNJ-73763989

JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.

DRUG

Placebo for JNJ-73763989

Placebo for JNJ-73763989 will be administered as subcutaneous injection.

DRUG

JNJ-56136379

JNJ-56136379 tablets will be administered orally.

DRUG

Placebo for JNJ-56136379

Placebo for JNJ-56136379 tablets will be administered orally.

DRUG

Nucleos(t)ide Analog (NA)

NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.

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
2019-08-01
Primary Completion
2021-03-29
Completion
2022-04-26
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Russia
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • 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 NCT03982186 on ClinicalTrials.gov