CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
JNJ-73763989 +6 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/NCT04129554
NCT04129554Phase 2Completed
CompareCT.gov

A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Janssen Sciences Ireland UC·interventional·Posted Oct 17, 2019·Updated Feb 4, 2025

In Brief

A Phase 2 clinical trial evaluating JNJ-73763989, JNJ-56136379, and 5 other interventions for Hepatitis B, Chronic. Completed, enrolled 130 participants across 41 sites in 7 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesBelgium, France, Germany, Italy, Poland, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 17, 2019
Enrollment StartNov 6, 2019
Primary CompletionJul 8, 2021
Study CompletionJun 9, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.7 years ago

Interventions

JNJ-73763989drug

JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.

JNJ-56136379drug

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

Placebo for JNJ-73763989drug

Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.

Placebo for JNJ-56136379drug

Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.

Entecavir (ETV) monohydratedrug

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

Tenofovir disoproxil fumarate (TDF)drug

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

Tenofovir alafenamide (TAF)drug

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