A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Phase 2 Completed 48 enrolled Janssen Research & Development, LLC

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 + nucleos\[t\]ide analog \[NA\] and pegylated interferon alpha-2a \[PegIFN-alpha2a\]).

Timeline

Start: 2021-02-01
Primary completion: 2022-05-16
Completion: 2023-04-17

Publications

Gane E, Janczewska E, Takehara T, Chuang WL, Peng CY, Hlebowicz M, Asahina Y, Chang TT, Kalmeijer R, Jezorwski J, Kim G, Anastasiou Z, Kakuda TN, Verbinnen T, Pehlivanov N, Bakala A, Lenz O, Biermer M. Peginterferon-alpha-2a add-on to treatment with siRNA JNJ-73763989 in virologically suppressed chronic hepatitis B: The phase II PENGUIN study. JHEP Rep. 2025 Jul 9;7(10):101516. doi: 10.1016/j.jhepr.2025.101516. eCollection 2025 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JNJ-73763989	Small interfering RNA (siRNA)	—	Subcutaneous
Subject	PegIFN-alpha-2a	Protein / enzyme biologic	—	Subcutaneous
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 Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Summary

Timeline

Publications

Drugs

Indications