CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
JNJ-73763989 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04535544
NCT04535544Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

Janssen Research & Development, LLC·interventional·Posted Sep 2, 2020·Updated Apr 25, 2025

In Brief

A Phase 2 clinical trial evaluating JNJ-73763989, Placebo, and 3 other interventions for Hepatitis D, Chronic. Completed, enrolled 52 participants across 61 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis D, Chronic
CountriesAustralia, Brazil, China, France, Germany, Italy, Japan, New Zealand, Russia, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 2, 2020
Enrollment StartSep 17, 2020
Primary CompletionOct 19, 2023
Study CompletionMar 5, 2025
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 5.8 years ago

Interventions

JNJ-73763989drug

JNJ-73763989 will be administered as a SC injection.

Placebodrug

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

Entecavir (ETV) monohydratedrug

ETV monohydrate film coated tablet will be administered orally.

Tenofovir disoproxildrug

Tenofovir disoproxil film-coated tablet will be administered orally.

Tenofovir alafenamide (TAF)drug

TAF film coated tablet will be administered orally.