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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225335

Enrollment

Registered

2020-08-21

Start date

2021-01-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Interventions

investigational material(s) Generic name etc : JNJ-73763989 INN of investigational material : - Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=) 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

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-alfa 2a

Design outcomes

Primary

Measure	Time frame
efficacy Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance 24 Weeks After Stopping all Study Interventions of Consolidation Phase and Without Restarting NA Treatment Up to Follow-up Week 24 Percentage of participants with HBsAg seroclearance 24 weeks after stopping all study interventions of consolidation phase and without restarting nucleos(t)ide analog (NA) treatment will be reported.	—

Measure

Time frame

efficacy Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance 24 Weeks After Stopping all Study Interventions of Consolidation Phase and Without Restarting NA Treatment Up to Follow-up Week 24 Percentage of participants with HBsAg seroclearance 24 weeks after stopping all study interventions of consolidation phase and without restarting nucleos(t)ide analog (NA) treatment will be reported.

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Secondary

Measure	Time frame
safety Number of Participants with Adverse Events (AEs) and Serious Aes Up to Week 102 An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. safety Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters Up to Week 102 Number of participants with clinically significant abnormalities in laboratory parameters (hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, and renal biomarkers) will be reported. safety Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs) Up to Week 102 Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported. safety Number of Participants with Clinically Significant Abnormalities in Vital Signs Up to Week 102 Number of participants with clinically significant abnormalities in vital signs (systolic and diastolic blood pressure, pulse rate, and body temperature) will be reported. safety Number of Participants with Clinically Significant Abnormalities in Physical Examination Up to Week 102 Number of participants with clinically significant abnormalities in physical examination will be reported. efficacy Percentage of Participants Reaching HBsAg less than () 1 log10 IU/mL from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below <LLOQ of the HBV DNA assay) will be reported. efficacy Percentage of Participants who Reach Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Undetectability After Re-start of NA Treatment During Follow-	—

Measure

Time frame

safety Number of Participants with Adverse Events (AEs) and Serious Aes Up to Week 102 An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. safety Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters Up to Week 102 Number of participants with clinically significant abnormalities in laboratory parameters (hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, and renal biomarkers) will be reported. safety Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECGs) Up to Week 102 Number of participants with clinically significant abnormalities in electrocardiogram (ECGs) will be reported. safety Number of Participants with Clinically Significant Abnormalities in Vital Signs Up to Week 102 Number of participants with clinically significant abnormalities in vital signs (systolic and diastolic blood pressure, pulse rate, and body temperature) will be reported. safety Number of Participants with Clinically Significant Abnormalities in Physical Examination Up to Week 102 Number of participants with clinically significant abnormalities in physical examination will be reported. efficacy Percentage of Participants Reaching HBsAg less than () 1 log10 IU/mL from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below <LLOQ of the HBV DNA assay) will be reported. efficacy Percentage of Participants who Reach Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Undetectability After Re-start of NA Treatment During Follow-

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Countries

Asia except Japan, Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026