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
  • End date
    Jan 5, 2023
  • participants needed
    50
  • sponsor
    Janssen Research & Development, LLC
Updated on 21 April 2021

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].

Description

This study is an intervention specific appendix to the Hepatitis B wings platform trial (PLATFORMPAHPB2001).

Details
Condition chronic hepatitis b
Treatment Tenofovir disoproxil, JNJ-56136379, Tenofovir alafenamide (TAF), JNJ-73763989, Entecavir (ETV) monohydrate, PegIFN-alpha2a
Clinical Study IdentifierNCT04667104
SponsorJanssen Research & Development, LLC
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

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
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