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A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

NCT04585789 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-21

Study results available
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Summary

The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.

Conditions

Interventions

DRUG

JNJ-73763989

JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44.

DRUG

JNJ-56136379

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

DRUG

Entecavir (ETV)

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

DRUG

Tenofovir disoproxil

Tenofovir disoproxil 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.

DRUG

PegIFN-alpha-2a (Optional)

PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-11
Primary Completion
2023-02-08
Completion
2024-01-09
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • New Zealand
  • Poland
  • United Kingdom

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 NCT04585789 on ClinicalTrials.gov