A Study of 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

Phase 2 Completed 130 enrolled Janssen Sciences Ireland UC

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2019-11-06
Primary completion: 2021-07-08
Completion: 2022-06-09

Publications

Agarwal K, Buti M, van Bommel F, Lampertico P, Janczewska E, Bourliere M, Vanwolleghem T, Lenz O, Verbinnen T, Kakuda TN, Mayer C, Jezorwski J, Muenz D, Beumont M, Kalmeijer R, Biermer M, Lonjon-Domanec I. JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analogue-suppressed patients with chronic hepatitis B: REEF-2. J Hepatol. 2024 Sep;81(3):404-414. doi: 10.1016/j.jhep.2024.03.046. Epub 2024 Apr 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-73763989	Small interfering RNA (siRNA)	200 mg	Subcutaneous
Subject	bersacapavir	Other / unclassified	250 mg	Oral
Background	Entecavir	Small molecule	—	Oral
Background	Tenofovir disoproxil fumarate	Small molecule	—	Oral
Background	tenofovir alafenamide	Small molecule	—	Oral

A Study of 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

Summary

Timeline

Publications

Drugs

Indications