A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
NCT ID: NCT04535544
Last Updated: 2025-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2020-09-17
2025-03-05
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
DOUBLE
Study Groups
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Immediate Active Treatment arm: JNJ-73763989 + NA
Participants will receive JNJ-73763989 subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\], tenofovir disoproxil, or tenofovir alafenamide \[TAF\]) once daily for 144 Weeks in Part 1 and for at least 96 weeks in Part 2.
JNJ-73763989
JNJ-73763989 will be administered as a SC injection.
Entecavir (ETV) monohydrate
ETV monohydrate film coated tablet will be administered orally.
Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally.
Tenofovir alafenamide (TAF)
TAF film coated tablet will be administered orally.
Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA
Participants will receive matching placebo to JNJ-73763989 SC injection Q4W along with NA (ETV, tenofovir disoproxil, or TAF) once daily for 52 Weeks followed by JNJ-73763989 SC injection Q4W along with NA once daily for 96 weeks in Part 1 and for at least 48 weeks in Part 2.
JNJ-73763989
JNJ-73763989 will be administered as a SC injection.
Placebo
Matching placebo to JNJ-73763989 will be administered as a SC injection.
Entecavir (ETV) monohydrate
ETV monohydrate film coated tablet will be administered orally.
Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally.
Tenofovir alafenamide (TAF)
TAF film coated tablet will be administered orally.
Interventions
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JNJ-73763989
JNJ-73763989 will be administered as a SC injection.
Placebo
Matching placebo to JNJ-73763989 will be administered as a SC injection.
Entecavir (ETV) monohydrate
ETV monohydrate film coated tablet will be administered orally.
Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally.
Tenofovir alafenamide (TAF)
TAF film coated tablet will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
* For Part 1: hepatitis D RNA (HDV RNA) greater than or equal to (\>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values \>= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (\<=) 10000 IU/mL at screening or HDV RNA values at screening are \<= 100000 IU/mL
* Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
* 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
* Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of \>= 140000 per deciliter (dL) for enrollment into Part-2
Exclusion Criteria
* History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
* Evidence of liver disease of non-HBV/HDV etiology
* Signs of hepatocellular carcinoma (HCC)
* Significant laboratory abnormalities as defined in the protocol at screening
* Participants with a history of malignancy within 5 years before screening
* Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
* History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
* Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
* History of or current clinically significant skin disease or drug rash
* Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients or excipients of the placebo content
* Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
* Participants who have taken any therapies disallowed per protocol
* Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
* Male participants who plan to father a child while enrolled
* Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
* Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)
18 Years
65 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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Stanford University School of Medicine
Redwood City, California, United States
Harvard Medical School Massachusetts General Hospital
Boston, Massachusetts, United States
Royal Prince Alfred Hospital
Camperdown, , Australia
Western Health
Footscray, , Australia
Westmead Hospital
Westmead, , Australia
Centro Oncológico De Roraima
Boa Vista, , Brazil
Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
Manaus, , Brazil
Cepem - Centro de Pesquisa Em Medicina Tropical
Porto Velho, , Brazil
Beijing Ditan Hospital Capical Medical University
Beijing, , China
Peking University People s Hospital
Beijing, , China
The First Bethune Hospital of Jilin University
Changchun, , China
West China Hospital Sichuan University
Chengdu, , China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, , China
Nanfang Hospital
Guangzhou, , China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, , China
Huashan Hospital Fudan University
Shanghai, , China
Hopital Beaujon
Clichy, , France
Hopital de La Croix Rousse
Lyon, , France
CHU de Nantes hotel Dieu
Nantes, , France
CHU Hopital Saint Antoine
Paris, , France
Chu Rennes Hopital Pontchaillou
Rennes, , France
Universitatsklinikum Essen
Essen, , Germany
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
Frankfurt, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Irccs Ospedale Maggiore Di Milano
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
Rome, , Italy
Ospedale Molinette, AO Città della Salute e della Scienza di
Torino, , Italy
Tokyo Medical and Dental University Hospital
Bunkyō City, , Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, , Japan
National Hospital Organization Shikoku Cancer Center
Iizuka-shi, , Japan
Ikeda City Hospital
Ikeda, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Kumamoto Shinto General Hospital
Kumamoto, , Japan
Nagasaki University Hospital
Nagasaki, , Japan
National Hospital Organization Nagasaki Medical Center
Nagasaki, , Japan
University of the Ryukyus Hospital
Nakagami Gun, , Japan
Nakagami Hospital
Okinawa, , Japan
Suita Municipal Hospital
Suita, , Japan
Osaka University Hospital
Suita-shi, , Japan
Tokyo Metropolitan Bokutoh Hospital
Sumida Ku, , Japan
New Zealand Clinical Research
Auckland, , New Zealand
Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
Krasnoyarsk, , Russia
St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
Saint Petersburg, , Russia
Medical Company Hepatolog Ltd
Samara, , Russia
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Danderyds Sjukhus
Danderyd, , Sweden
Skanes universitetssjukhus
Malmo, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
China Medical University Hospital
Tiachung, , Taiwan
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Ege University Medical of Faculty, Department of Gastroenterology
Izmir, , Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, , Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, , Turkey (Türkiye)
Kings College Hospital
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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2020-001249-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
73763989HPB2004
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506763-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108868
Identifier Type: -
Identifier Source: org_study_id
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