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)
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- STATUS
- Recruiting
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- End date
- Oct 15, 2023
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- participants needed
- 80
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- sponsor
- Janssen Research & Development, LLC
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 Identifier | NCT04439539 |
| Sponsor | Janssen Research & Development, LLC |
| Last Modified on | 11 April 2021 |
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