CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 232 enrolled
Drug / intervention
JNJ-56136379 +2 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/NCT03361956
NCT03361956Phase 2Completed

A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)Ide Analog in Subjects With Chronic Hepatitis B Virus Infection

Janssen Sciences Ireland UC·interventional·Posted Dec 5, 2017·Updated Nov 17, 2022

In Brief

A Phase 2 clinical trial evaluating JNJ-56136379, Placebo, and 1 other intervention for Hepatitis B. Completed, enrolled 232 participants across 76 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesBelgium, Canada, China, France, Germany, Hong Kong, Italy, Japan, Malaysia, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedDec 5, 2017
Enrollment StartFeb 13, 2018
Primary CompletionSep 5, 2019
Study CompletionAug 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.6 years ago

Interventions

JNJ-56136379drug

Participants will receive JNJ-56136379 tablet orally.

Placebodrug

Participants will receive matching placebo tablet orally.

NA (ETV or TDF)drug

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