A Study of JNJ-73763989 + JNJ-56136379 + Nucleos(t)Ide Analog (NA) Regimen With or Without Pegylated Interferon Alpha-2a (PegIFN- 2a) in Treatment-Naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection and Normal Alanine Aminotransferase (ALT)

  • STATUS
    Recruiting
  • End date
    Oct 15, 2023
  • participants needed
    80
  • sponsor
    Janssen Research & Development, LLC
Updated on 11 April 2021

Summary

The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + JNJ-56136379 + nucleos(t)ide analog (NA) with or without pegylated interferon alpha-2a (PegIFN-2a).

Description

Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the human liver. The acute phase of infection is either followed by an immune controlled state or progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg) seroclearance is currently considered to be associated with the most thorough suppression of HBV replication (termed functional cure). With current available NA treatment strategies, rate of HBsAg seroclearance remains very low (around 3 percent [%]) even under long-term treatment. Also, with the persistently high global prevalence of HBV-associated mortality, there is a medical need for more effective finite treatment options that lead to sustained HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via a ribonucleic acid interference (RNAi) mechanism. JNJ-56136379 is an orally administered capsid assembly modulator (CAM) that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + JNJ-56136379 + NA with or without PegIFN-2a in participants with hepatitis B e antigen (HBeAg) positive chronic infection. The study will be conducted in 4 phases: a screening phase, an induction phase with flexible duration, a consolidation phase with or without PegIFN-2a and a follow-up phase. Safety assessments will include Adverse Events (AEs), serious AEs of the study interventions, clinical laboratory tests, Electrocardiograms (ECGs), vital signs, and physical examinations.

Details
Condition chronic hepatitis b
Treatment Tenofovir disoproxil, JNJ-56136379, JNJ-73763989, PegIFN-α2a
Clinical Study IdentifierNCT04439539
SponsorJanssen Research & Development, LLC
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have chronic hepatitis b??
Is your age between 18 yrs and 55 yrs?
Is your age between 18 yrs and 55 yrs?
Is your age between 18 yrs and 55 yrs?
Is your age between 18 yrs and 55 yrs?
Medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead Electrocardiogram (ECG) at screening
Currently not treated chronic hepatitis B virus (HBV) infection with normal alanine transaminase (ALT) and HBV deoxyribonucleic acid (DNA) greater than or equal to (>=) 20,000 international units per milliliter (IU/mL)
Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than or equal to (<=) 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 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
Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
Contraindications to the use of PegIFN-2a
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