NCT03361956

An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Janssen Sciences Ireland UC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main study consists of 2-parts and each part will consist of 2 types of Chronic Hepatitis B-infected participant populations. Each part of the study will consist of screening phase (up to 8 weeks), treatment phase (24 weeks or 48 weeks, depending on treatment response), and post-treatment follow-up phase (24 weeks or 48 weeks, depending on treatment response). The duration of individual participation will be up to approximately 56 weeks (participants not eligible to continue treatment in extension phase), up to 80 weeks (participants continuing treatment in extension phase but not meeting treatment completion criteria), or up to 104 weeks (participants meeting treatment completion criteria). The safety and efficacy will be monitored throughout the study. In a separate substudy, at selected clinical sites, percutaneous core liver biopsy will be performed to evaluate changes of intrahepatic viral parameters.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	JNJ-56136379	Participants will receive JNJ-56136379 tablet orally.
DRUG	Placebo	Participants will receive matching placebo tablet orally.
DRUG	NA (ETV or TDF)	Participants will receive NA (ETV or TDF) tablet orally as per approved label.

Timeline

• Start date: 2018-02-13
• Primary completion: 2019-09-05
• Completion: 2020-08-13
• First posted: 2017-12-05
• Last updated: 2022-11-17
• Results posted: 2022-11-17

Locations

76 sites across 19 countries: United States, Belgium, Canada, China, France, Germany, Hong Kong, Italy, Japan, Malaysia, Poland, Russia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study