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

NCT05005507 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-03-06

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) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment).

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

JNJ-73763989

JNJ-73763989 will be administered subcutaneously once every 4 weeks.

DRUG

PegIFN-alpha-2a

PegIFN-alpha-2a will be administered subcutaneously once weekly.

DRUG

Tenofovir disoproxil

Tenofovir disoproxil film-coated tablet will be administered orally once daily.

DRUG

TAF

TAF film-coated tablet will be administered orally once daily.

DRUG

ETV

ETV film-coated tablet will be administered orally once daily.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2021-12-29
Completion
2021-12-29
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan
  • Poland
  • Spain
  • 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 NCT05005507 on ClinicalTrials.gov