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An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

NCT03361956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2022-11-17

Study results available
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Summary

The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

Conditions

Interventions

DRUG

JNJ-56136379

Participants will receive JNJ-56136379 tablet orally.

DRUG

Placebo

Participants will receive matching placebo tablet orally.

DRUG

NA (ETV or TDF)

Participants will receive NA (ETV or TDF) tablet orally as per approved label.

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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2019-09-05
Completion
2020-08-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03361956 on ClinicalTrials.gov