A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)ide Analogs in Participants With Chronic Hepatitis B Virus Infectio

Phase 2

• Conditions: Hepatitis B, Chronic

• Registration Number: JPRN-jRCT2061210044
• Lead Sponsor: akama Takahiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Participants must have a body mass index between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive
- Participants with chronic hepatitis B who should: a) be chronic hepatitis B e antigen (HBeAg) -negative; b) be anti-HBe antibody-positive; c) be currently receiving nucleos(t)ide analog (NA) treatment for at least 2 years prior to screening; d) have serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than (<) 60 international unit/milliliter (IU/mL) on 2 sequential measurements at least 6 months apart; e) have alanine aminotransferase (ALT) values < 2.0x upper limit of normal (ULN) on 2 sequential measurements at least 6 months apart
- Hepatitis B surface antigen (HBsAg) greater than (>) 5 IU/mL at screening
- Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (kPa) within 6 months prior to screening

Exclusion Criteria

- History or signs of cirrhosis or portal hypertension
- Evidence of hepatitis A, C, D, E virus infection, or human immunodeficiency virus (HIV) infection
- Liver disease of non-HBV etiology
- Clinically relevant alcohol or drug abuse within 12 months of screening
- Participants who meet any of the additional exclusion criteria for pegylated interferon alpha-2a (PegIFN-alpha2a) as described in local prescribing information (example, refer to Pegasys SmPC or Pegasys USPI) per the investigator's discretion. Key exclusion criteria for PegIFN-alpha2a include: a) Participants with signs or symptoms compatible with autoimmune disorders. b) Participants with bone marrow suppression. c) Participants with hypoglycaemia, hyperglycaemia, and/or diabetes mellitus, who cannot be effectively controlled by medication. d) Participants with pre-existing ophthalmologic disorders. e) Participants with one or more of the following laboratory abnormalities: i) Absolute neutrophil count less than (<)1,500 cells/mm3 (<1,000 cells/mm3 for black or African American participants). ii) Serum creatinine >1.5x ULN. iii) Inadequately controlled thyroid function (thyroid stimulating hormone [TSH] and thyroxine [T4]). f) Participants with a history of a severe psychiatric disorder including severe depression, suicidal ideation and attempted suicide, or a current depression or other psychiatric disorder that is not adequately controlled on a stable medication regimen

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Reduction of at least 2log10 IU/ml in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline at Week 24 (EOSI): Week 24:Percentage of participants with a reduction of at least 2 log10 international units per milliliters (IU/mL) in HBsAg levels from baseline at Week 24 (end of study intervention [EOSI]) will be reported.