Overview

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