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A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

NCT04535544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-04-25

Study results available
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Summary

The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.

Conditions

  • Hepatitis D, Chronic

Interventions

DRUG

JNJ-73763989

JNJ-73763989 will be administered as a SC injection.

DRUG

Placebo

Matching placebo to JNJ-73763989 will be administered as a SC injection.

DRUG

Entecavir (ETV) monohydrate

ETV monohydrate film coated tablet will be administered orally.

DRUG

Tenofovir disoproxil

Tenofovir disoproxil film-coated tablet will be administered orally.

DRUG

Tenofovir alafenamide (TAF)

TAF film coated tablet will be administered orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

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
2020-09-17
Primary Completion
2023-10-19
Completion
2025-03-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • China
  • France
  • Germany
  • Italy
  • Japan
  • New Zealand
  • Russia
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04535544 on ClinicalTrials.gov