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
Completed · Phase 2
Conditions studied: Hepatitis B, Chronic
In brief
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).
Key facts
- Study ID
- NCT04439539
- Run by
- Janssen Research & Development, LLC
- People needed
- 54
- Starts
- 2020-09-14
- Expected to finish
- 2024-02-13
- Last updated by the study team
- 2025-06-24
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
- Contraindications to the use of PegIFN-α2a
Where it is running
- Ruane Clinical Research Group Inc — Los Angeles, California, United States
- UPMC Center For Liver Diseases — Pittsburgh, Pennsylvania, United States
- Liver Institute Northwest — Seattle, Washington, United States
- University of Calgary — Calgary, Alberta, Canada
- GI Research Institute (G.I.R.I.) — Vancouver, British Columbia, Canada
- Vancouver ID Research and Care Centre Society — Vancouver, British Columbia, Canada
- Toronto General Hospital — Toronto, Ontario, Canada
- Hopital Beaujon — Clichy, France
- CHU de Grenoble Hopital Albert Michallon — Grenoble, France
- Hopital de La Croix Rousse — Lyon, France
- CHU Nantes - Hotel Dieu — Nantes, France
- CHU Hopital Saint Antoine — Paris, France
- Chu Rennes Hopital Pontchaillou — Rennes, France
- CHU Nancy Brabois — Vandœuvre-lès-Nancy, France
- Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH — Berlin, Germany
- Universitatsklinikum Essen — Essen, Germany
- Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1 — Frankfurt, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- Hiroshima University Hospital — Hiroshima, Japan
- Nara Medical University Hospital — Kashihara, Japan
- Musashino Red Cross Hospital — Musashino, Japan
- Nagoya City University Hospital — Nagoya, Japan
- Yokohama City University Medical Center — Yokohama, Japan
- Irkutsk State Medical University — Irkutsk, Russia
- Republic Clinical Infectious Hospital n.a. AF Agafonov — Kazan', Russia
Full record on ClinicalTrials.gov
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