Overview

A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Status:
Recruiting
Trial end date:
2023-05-04
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) levels of the study intervention (that is, JNJ-73763989 + JNJ-56136379 + nucleos[t]ide analog [NA] and pegylated interferon alpha-2a [PegIFN-alpha2a].
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Entecavir
Peginterferon alfa-2a
Tenofovir
Criteria
Inclusion Criteria:

- Chronic hepatitis B virus (HBV) infection, hepatitis B e Antigen (HBeAg) positive or
negative with suppressed viral replication under nucleos(t)ide analogue treatment for
at least 6 months prior to screening

- Medically stable based on physical examination, medical history, vital signs, and
12-lead electrocardiogram (ECG) performed at screening

- Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2),
extremes included

- Must have serum HBsAg greater than (>) 100 international units per milliliter (IU/mL)
at screening, as assessed by quantitative HBsAg assay

- Must have a fibroscan stiffness measurement less than or equal to (<=) 9.0 Kilopascal
(kPa) at screening

Exclusion Criteria:

- Evidence of hepatitis A, C, D or E virus infection or human immunodeficiency, virus
type 1 (HIV) 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

- Contraindications to the use of pegylated interferon alpha-2a