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
Sites (55)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| Western Health Coordinator of this site? Confirm its status | Footscray | Australia | Unknown status |
| Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Centro Oncologico de Roraima Coordinator of this site? Confirm its status | Boa Vista | Brazil | Unknown status |
| Fundação de Medicina Tropical Doutor Heitor Vieira Dourado Coordinator of this site? Confirm its status | Manaus | Brazil | Unknown status |
| Cepem - Centro de Pesquisa Em Medicina Tropical Coordinator of this site? Confirm its status | Porto Velho | Brazil | Unknown status |
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Ditan Hospital Capical Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Bethune Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangzhou Eighth People's Hospital, Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University College of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Universitätsklinikum Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1 Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Hosp Univ Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. Marques de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Completed |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Universita' Degli Studi Di Roma La Sapienza Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Completed |
| Tokyo Medical and Dental University Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| National Hospital Organization Shikoku Cancer Center Coordinator of this site? Confirm its status | Iizuka-shi | Japan | Unknown status |
| Ikeda City Hospital Coordinator of this site? Confirm its status | Ikeda | Japan | Unknown status |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Kumamoto Shinto General Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| National Hospital Organization Nagasaki Medical Center Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| University of the Ryukyus Hospital Coordinator of this site? Confirm its status | Nakagami Gun | Japan | Unknown status |
| Nakagami Hospital Coordinator of this site? Confirm its status | Okinawa | Japan | Unknown status |
| Suita Municipal Hospital Coordinator of this site? Confirm its status | Suita | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Tokyo Metropolitan Bokutoh Hospital Coordinator of this site? Confirm its status | Sumida-ku | Japan | Unknown status |
| New Zealand Clinical Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Unknown status |
| St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Medical Company Hepatolog Ltd Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Huddinge | Sweden | Completed |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Tiachung | Taiwan | Unknown status |
| Harvard Medical School-Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Stanford University School of Medicine Coordinator of this site? Confirm its status | Redwood City | United States | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Ege University Medical of Faculty, Department of Gastroenterology Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Kocaeli University Medical Faculty Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
| Karadeniz Teknik University Medical Faculty Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.