At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
In Brief
A Phase 2 clinical trial evaluating JNJ-73763989, Placebo for JNJ-73763989, and 3 other interventions for Hepatitis B, Chronic. Completed, enrolled 471 participants across 108 sites in 19 countries.
Detailed Summary
The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.
Study Details
Timeline
Interventions
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.
Placebo for JNJ-73763989 will be administered as subcutaneous injection.
JNJ-56136379 tablets will be administered orally.
Placebo for JNJ-56136379 tablets will be administered orally.
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.