A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

• Status: Active, not recruiting
• Trial end date: 2022-08-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC; Janssen Sciences Ireland UC
• Treatments: Entecavir; Tenofovir

Criteria

Inclusion Criteria:

• Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening

• Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening

• Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment for at least 24 months prior to screening

• Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening

• Body mass index (BMI) between 18.0 and 35 kilogram per meter square (kg/m^2), extremes included

• Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential

• Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 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/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol

• Evidence of liver disease of non-HBV etiology

• History or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellular carcinoma (HCC)

• Significant laboratory abnormalities as defined in the protocol at screening

• Participants with a history of malignancy within 5 years before screening

• Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol

• History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease

• Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant

• History of or current clinically significant skin disease or drug rash

• Known allergies, hypersensitivity, or intolerance to JNJ-73763989 and JNJ-56136379 or their excipients or to placebo content

• Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF) per local prescribing information

• Participants who have taken any therapies disallowed per protocol