A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

NCT ID: NCT04585789

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2024-01-09

Brief Summary

The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.

Detailed Description

The title of protocol reflects the original study design. The study design section is reflecting that the design as of protocol amendment 5 is non-randomized.

Conditions

Hepatitis B

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Panel 1: JNJ-73763989+ NA

Ongoing and new participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (last injection at Week 44) and nucleos(t)ide analog (NA) treatment (either entecavir \[ETV\], tenofovir disoproxil or tenofovir alafenamide \[TAF\] tablets) once daily up to 48 weeks. Participants may receive optional treatment with pegylated interferon alpha-2a (PegIFN-alpha-2a) after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44.

JNJ-56136379

Intervention Type: DRUG

JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.

Entecavir (ETV)

Intervention Type: DRUG

ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.

Tenofovir disoproxil

Intervention Type: DRUG

Tenofovir disoproxil will be administered orally once daily up to 48 weeks as NA treatment.

Tenofovir alafenamide (TAF)

Intervention Type: DRUG

TAF will be administered orally once daily up to 48 weeks as NA treatment.

PegIFN-alpha-2a (Optional)

Intervention Type: DRUG

PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.

Panel 2: JNJ-73763989+ NA

Ongoing and new participants will receive JNJ-73763989 SC injection once every 4 weeks (last injection at Week 44) and NA treatment (ETV, tenofovir disoproxil or TAF tablets) once daily up to 48 weeks. Participants may receive optional treatment with PegIFN-alpha-2a after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44.

JNJ-56136379

Intervention Type: DRUG

JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.

Entecavir (ETV)

Intervention Type: DRUG

ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.

Tenofovir disoproxil

Intervention Type: DRUG

Tenofovir disoproxil will be administered orally once daily up to 48 weeks as NA treatment.

Tenofovir alafenamide (TAF)

Intervention Type: DRUG

TAF will be administered orally once daily up to 48 weeks as NA treatment.

PegIFN-alpha-2a (Optional)

Intervention Type: DRUG

PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.

Interventions

JNJ-73763989

JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44.

Intervention Type: DRUG

JNJ-56136379

JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.

Intervention Type: DRUG

Entecavir (ETV)

ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.

Intervention Type: DRUG

Tenofovir disoproxil

Tenofovir disoproxil will be administered orally once daily up to 48 weeks as NA treatment.

Intervention Type: DRUG

Tenofovir alafenamide (TAF)

TAF will be administered orally once daily up to 48 weeks as NA treatment.

Intervention Type: DRUG

PegIFN-alpha-2a (Optional)

PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Medically stable on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiogram (ECG) performed at screening
• Hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening: participants be either currently not treated with HBeAg positive status or virologically (nucleos[t]ide analog [NA]) suppressed with HBeAg negative status
• Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening
• Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
• Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
• Fibroscan liver stiffness measurement less than and equal to (<=) 9 Kilopascal (kPa) within 6 months prior to screening or at the time of screening

Exclusion Criteria

• Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
• History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
• History or signs of cirrhosis or portal hypertension, signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening
• Presence of coagulopathy or bleeding disorder as indicated by: (a) International normalized ratio (INR) greater than or equal to (>=) 1.1* upper limit of normal (ULN); (b) Partial thromboplastin time >1.1*ULN; (c) Any signs of prolonged bleeding (>10 minutes)
• Presence of hemoglobinopathy (including sickle cell disease, thalassemia)
• Liver biopsy performed prior to screening that led to complications and that in the opinion of the investigator would prohibit another liver biopsy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Johns Hopkins University

Baltimore, Maryland, United States

UZ Antwerpen

Edegem, , Belgium

Toronto General Hospital

Toronto, Ontario, Canada

Hopital Beaujon

Clichy, , France

University Medical Center

Hamburg, , Germany

Irccs Ospedale Maggiore Di Milano

Milan, , Italy

New Zealand Clinical Research

Auckland, , New Zealand

ID Clinic

Mysłowice, , Poland

Grahame Hayton Unit

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Countries

United States; Belgium; Canada; France; Germany; Italy; New Zealand; Poland; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

73763989HPB2003

Identifier Type: OTHER

Identifier Source: secondary_id

2019-004475-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR108790

Identifier Type: -

Identifier Source: org_study_id