An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
NCT ID: NCT05275023
Last Updated: 2025-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2022-06-30
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA)
Participants will receive JNJ-73763989 subcutaneous (SC) injections and single dose of programmed cell death protein receptor-1 (PD-1) inhibitor as intravenous (IV) infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, tenofovir alafenamide \[TAF\] or entecavir \[ETV\]).
JNJ-73763989
JNJ-73763989 will be administered subcutaneously.
PD-1 inhibitor
PD-1 inhibitor will be administered as IV infusion.
Tenofovir Disoproxil
Tenofovir disoproxil film-coated tablets will be administered orally.
Tenofovir Alafenamide
TAF film-coated tablets will be administered orally.
Entecavir
ETV film-coated tablets will be administered orally.
Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA
Participants will receive JNJ-73763989 SC injections and multiple doses of PD-1 inhibitor as IV infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, TAF or ETV).
JNJ-73763989
JNJ-73763989 will be administered subcutaneously.
PD-1 inhibitor
PD-1 inhibitor will be administered as IV infusion.
Tenofovir Disoproxil
Tenofovir disoproxil film-coated tablets will be administered orally.
Tenofovir Alafenamide
TAF film-coated tablets will be administered orally.
Entecavir
ETV film-coated tablets will be administered orally.
Interventions
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JNJ-73763989
JNJ-73763989 will be administered subcutaneously.
PD-1 inhibitor
PD-1 inhibitor will be administered as IV infusion.
Tenofovir Disoproxil
Tenofovir disoproxil film-coated tablets will be administered orally.
Tenofovir Alafenamide
TAF film-coated tablets will be administered orally.
Entecavir
ETV film-coated tablets will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have fibroscan liver stiffness measurement less than or equal to (\<=) 9.0 kilopascal (kPa) or a liver biopsy result classified as metavir F0-F2
Exclusion Criteria
* History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities
* Participants with personal/familial history/indicative of immune-mediated disease risk
18 Years
55 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Kings College Hospital
London, , United Kingdom
Toronto General Hospital
Toronto, Ontario, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
IKEM
Prague, , Czechia
Hopital Beaujon
Clichy, , France
Hopital Saint Joseph
Marseille, , France
Chu Rennes Hopital Pontchaillou
Rennes, , France
CHRU Nancy Brabois
Vandœuvre-lès-Nancy, , France
Fondazione IRCCS Ca Granda Ospedale Policlinico Di Milano
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
Rome, , Italy
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Madrid, , Spain
Hosp. Montecelo
Pontevedra, , Spain
Hosp. Gral. Univ. Valencia
Valencia, , Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
E-DA Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, , Turkey (Türkiye)
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Imperial College London and Imperial College Healthcare NHS Trust
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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73763989PAHPB2008
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005132-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR109161
Identifier Type: -
Identifier Source: org_study_id
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