A Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection.

Phase 1

• Conditions: Chronic Hepatitis B Virus Infection; MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002450-81-PL
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-16
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

A01. Adult male or female participants =18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive.
M02. Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
A03. Participants must have chronic HBV infection.
M04. Participants must have a body mass index between 18.0 and 35.0 kg/m2, extremes included.
A05. Participants must sign a Master ICF and must sign the ICF specific for this intervention cohort, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

Please refer to the study protocol for a full list of inclusion criteria.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

A01. Participants with evidence of hepatitis A virus infection, HCV infection, hepatitis D virus infection, hepatitis E virus infection, or HIV-1 or HIV-2 infection at screening.
A02. Participants with evidence of hepatic decompensation at any time point prior to or at the time of screening.
M03. History or evidence of clinical signs or symptoms of hepatic decompensation.
M04. Participants with evidence of liver disease of non-HBV etiology.
A05. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities.

Please refer to the study protocol for a full list of exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy in terms of HBsAg changes from baseline for the treatment regimens.;Secondary Objective: 1. To evaluate the safety and tolerability of the study intervention.<br>2. To evaluate the efficacy of the study intervention during the follow-up period.<br>3. To evaluate the efficacy of the study intervention as measured by blood markers during the study intervention and follow-up (FU) period.<br>4. To evaluate the frequency of virologic breakthrough throughout the study.<br>5. To evaluate the PK of JNJ-3989, and optionally of NA and PegIFN-a2a.;Primary end point(s): Proportion of participants with an HBsAg level <100 IU/mL at Week 24.;Timepoint(s) of evaluation of this end point: Week 24.