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NCT04535544CompletedPhase 2

A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

Source: ClinicalTrials.gov · Last updated 22 Jul 2026

Brief summary (registry, in English)

The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
52 (actual)
First submitted
28 Aug 2020
Start date
17 Sept 2020
Primary completion date
19 Oct 2023
Lead sponsor
Janssen Research & Development, LLC
Diseases
Hepatitis B
NCT number
NCT04535544
EU CT number
2023-506763-33-00
EudraCT number
2020-001249-37

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 52
  • From 17 Sept 2020 to the primary completion date, 19 Oct 2023
  • 55 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have taken any therapies disallowed per protocol
  • Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant

Other illness

  • Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
  • Evidence of liver disease of non-HBV/HDV etiology
  • Participants with a history of malignancy within 5 years before screening
  • 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

Lab values

  • 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
  • Significant laboratory abnormalities as defined in the protocol at screening

Other

  • Signs of hepatocellular carcinoma (HCC)
  • Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
  • Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
  • 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
  • Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

Who the study is looking for

  • Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (55)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
Western Health
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FootscrayAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
Centro Oncologico de Roraima
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Boa VistaBrazilUnknown status
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
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ManausBrazilUnknown status
Cepem - Centro de Pesquisa Em Medicina Tropical
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Porto VelhoBrazilUnknown status
Peking University People's Hospital
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BeijingChinaUnknown status
Beijing Ditan Hospital Capical Medical University
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BeijingChinaUnknown status
The First Bethune Hospital of Jilin University
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ChangchunChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
The Second Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Nanfang Hospital
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GuangzhouChinaUnknown status
Guangzhou Eighth People's Hospital, Guangzhou Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University College of Medicine
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HangzhouChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Universitätsklinikum Essen
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EssenGermanyUnknown status
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
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FrankfurtGermanyUnknown status
Medizinische Hochschule Hannover
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HanoverGermanyUnknown status
Hosp Univ Vall D Hebron
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BarcelonaSpainUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Hosp. Univ. 12 de Octubre
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MadridSpainUnknown status
Hosp. Univ. Marques de Valdecilla
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SantanderSpainUnknown status
Hopital Beaujon
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ClichyFranceCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Kings College Hospital
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LondonUnited KingdomUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Universita' Degli Studi Di Roma La Sapienza
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RomeItalyCompleted
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyCompleted
Tokyo Medical and Dental University Hospital
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Bunkyō CityJapanUnknown status
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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HiroshimaJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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Iizuka-shiJapanUnknown status
Ikeda City Hospital
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IkedaJapanUnknown status
Kumamoto University Hospital
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KumamotoJapanUnknown status
Kumamoto Shinto General Hospital
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KumamotoJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
National Hospital Organization Nagasaki Medical Center
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NagasakiJapanUnknown status
University of the Ryukyus Hospital
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Nakagami GunJapanUnknown status
Nakagami Hospital
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OkinawaJapanUnknown status
Suita Municipal Hospital
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SuitaJapanUnknown status
Osaka University Hospital
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Suita-shiJapanUnknown status
Tokyo Metropolitan Bokutoh Hospital
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Sumida-kuJapanUnknown status
New Zealand Clinical Research
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AucklandNew ZealandUnknown status
Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
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KrasnoyarskRussiaUnknown status
St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
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Saint PetersburgRussiaUnknown status
Medical Company Hepatolog Ltd
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SamaraRussiaUnknown status
Karolinska University Hospital
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HuddingeSwedenCompleted
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
China Medical University Hospital
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TiachungTaiwanUnknown status
Harvard Medical School-Massachusetts General Hospital
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BostonUnited StatesUnknown status
Stanford University School of Medicine
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Redwood CityUnited StatesUnknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Ege University Medical of Faculty, Department of Gastroenterology
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IzmirTurkey (Türkiye)Unknown status
Kocaeli University Medical Faculty
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KocaeliTurkey (Türkiye)Unknown status
Karadeniz Teknik University Medical Faculty
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TrabzonTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.