NCT04667104

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

A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 \[PegIFN-alpha2a\]).

Detailed description

This study is an intervention specific appendix to the Hepatitis B wings platform trial (PLATFORMPAHPB2001). The study title reflects the original study design and JNJ-56136379 (JNJ-6379) was initially part of the study intervention but has been removed as part of amendment 3 of the study.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	JNJ-73763989	JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
DRUG	Tenofovir disoproxil	Tenofovir disoproxil film-coated tablet will be administered orally once daily.
DRUG	Tenofovir alafenamide (TAF)	TAF film-coated tablet will be administered orally once daily.
DRUG	Entecavir (ETV) monohydrate	ETV monohydrate film-coated tablet will be administered orally once daily.
DRUG	PegIFN-alpha2a	PegIFN-alpha2a injection will be administered subcutaneously once weekly.

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-05-16
• Completion: 2023-04-17
• First posted: 2020-12-14
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

11 sites across 4 countries: Japan, New Zealand, Poland, Taiwan

Regulatory

• FDA-regulated drug study