NCT04439539CompletedPhase 2
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection
Source: ClinicalTrials.gov · Last updated 24 Jun 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 18 Jun 2020
- Start date
- 14 Sept 2020
- Primary completion date
- 29 Aug 2023
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Hepatitis B
- NCT number
- NCT04439539
- EudraCT number
- 2019-004978-26
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 54
- From 14 Sept 2020 to the primary completion date, 29 Aug 2023
- 47 sites in 10 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 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, 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 or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
- Evidence of liver disease of non-HBV etiology
- Participants with a history of malignancy within 5 years before screening
Other
- Contraindications to the use of PegIFN-α2a
Who the study is looking for
- Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening
- Currently not treated chronic hepatitis B virus (HBV) infection with alanine transaminase (ALT) less than (\<) 2\* upper limit of normal (ULN) at screening and HBV deoxyribonucleic acid (DNA) greater than or equal to (\>=) 20,000 international units per milliliter (IU/mL)
- Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included
- Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than or equal to (\<=) 9 Kilopascal (kPa) at screening
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Toronto General Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Vancouver ID Research and Care Centre Society Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| GI Research Institute (G.I.R.I.) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH Coordinator of this site? Confirm its status | Berlin | Germany | 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 Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Univ Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Gral. Univ. Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| CHU De Grenoble Hopital Albert Michallon Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| CHU Nantes-Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Chu - Hôpital Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Rennes - Hopital Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| CHU Nancy-Brabois Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
| Glasgow Royal Infirmary Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| NHS Greater Glasgow and Clyde - Gartnavel General Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Grahame Hayton Unit Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Nara Medical University Hospital Coordinator of this site? Confirm its status | Kashihara | Japan | Unknown status |
| Musashino Red Cross Hospital Coordinator of this site? Confirm its status | Musashino | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Irkutsk State Medical University Coordinator of this site? Confirm its status | Irkutsk | Russia | Unknown status |
| Republic Clinical Infectious Hospital n.a. AF Agafonov Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Clinical Infectious Diseases Hospital n. a. S.P. Botkin Coordinator of this site? Confirm its status | Saint Petersburg | 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 |
| Smolensk Regional Clinical Hospital Coordinator of this site? Confirm its status | Smolensk | Russia | Unknown status |
| Stavropol State Medical University Coordinator of this site? Confirm its status | Stavropol | Russia | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Ruane Clinical Research Group Inc. Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UPMC - Center for Liver Diseases Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Liver Institute Northwest Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Hacettepe University Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ümraniye Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | 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 |
| Acibadem Mehmet Ali Aydinlar University Coordinator of this site? Confirm its status | Küçükçekmece | Turkey (Türkiye) | Unknown status |
| Karadeniz Teknik University Medical Faculty Coordinator of this site? Confirm its status | Trabzon | Turkey (Türkiye) | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.