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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

Full criteria on ClinicalTrials.gov

Sites (47)

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

SiteCityCountrySite status
University Of Calgary
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CalgaryCanadaUnknown status
Toronto General Hospital
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TorontoCanadaUnknown status
Vancouver ID Research and Care Centre Society
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VancouverCanadaUnknown status
GI Research Institute (G.I.R.I.)
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VancouverCanadaUnknown status
Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH
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BerlinGermanyUnknown 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 Clinic de Barcelona
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BarcelonaSpainUnknown status
Hosp Univ Vall D Hebron
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BarcelonaSpainUnknown status
Hosp. Gral. Univ. Valencia
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ValenciaSpainUnknown status
Hopital Beaujon
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ClichyFranceUnknown status
CHU De Grenoble Hopital Albert Michallon
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GrenobleFranceUnknown status
Hôpital de la Croix Rousse
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LyonFranceUnknown status
CHU Nantes-Hotel Dieu
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NantesFranceUnknown status
Chu - Hôpital Saint Antoine
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ParisFranceUnknown status
CHU Rennes - Hopital Pontchaillou
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RennesFranceUnknown status
CHU Nancy-Brabois
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Vandœuvre-lès-NancyFranceUnknown status
Glasgow Royal Infirmary
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GlasgowUnited KingdomUnknown status
NHS Greater Glasgow and Clyde - Gartnavel General Hospital
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GlasgowUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Grahame Hayton Unit
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LondonUnited KingdomUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Nara Medical University Hospital
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KashiharaJapanUnknown status
Musashino Red Cross Hospital
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MusashinoJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
Irkutsk State Medical University
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IrkutskRussiaUnknown status
Republic Clinical Infectious Hospital n.a. AF Agafonov
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Kazan'RussiaUnknown status
Clinical Infectious Diseases Hospital n. a. S.P. Botkin
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Saint PetersburgRussiaUnknown 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
Smolensk Regional Clinical Hospital
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SmolenskRussiaUnknown status
Stavropol State Medical University
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StavropolRussiaUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Ruane Clinical Research Group Inc.
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Los AngelesUnited StatesUnknown status
UPMC - Center for Liver Diseases
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PittsburghUnited StatesUnknown status
Liver Institute Northwest
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SeattleUnited StatesUnknown status
Hacettepe University Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ümraniye Training and Research Hospital
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IstanbulTurkey (Türkiye)Unknown 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
Acibadem Mehmet Ali Aydinlar University
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KüçükçekmeceTurkey (Türkiye)Unknown status
Karadeniz Teknik University Medical Faculty
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TrabzonTurkey (Türkiye)Unknown status

Related publications

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