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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

NCT04667104 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-07-03

Study results available
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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 \[PegIFN-alpha2a\]).

Conditions

  • Hepatitis B, Chronic

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-05-16
Completion
2023-04-17
FDA Drug
Yes

Countries

  • Japan
  • New Zealand
  • Poland
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667104 on ClinicalTrials.gov