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

CR108815

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).

2020-09-14

2023-08-29

2024-02-13

Completed

Early phase I

54

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

2024-03-28