A Phase 1b, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection (OSPREY)
The purpose of this study is to evaluate the efficacy of the study intervention based on
hepatitis B surface antigen (HBsAg) levels.
Description
JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to
treat chronic hepatitis B virus (HBV) infection via a ribonucleic acid interference (RNAi)
mechanism. JNJ-64300535 is a DNA vaccine encoding the core protein and the Polymerase (Pol)
protein of HBV. The therapeutic vaccine aims at inducing T-cell-specific immunity against HBV
antigens in participants with chronic hepatitis B (CHB). Selected nucleos(t)ide analogs (NAs)
used in this study are approved treatments of chronic HBV infection. This study is designed
to assess efficacy, safety, and tolerability of a 24-week (Day 1 to Week 24) combination
treatment with JNJ-73763989 + NA + JNJ-64300535. The study consists of a Screening phase (4
weeks), Treatment period with JNJ-73763989, NA and JNJ-64300535 (187 days), and a follow-up
period (FU Week 1 till FO Week 48). Safety will be assessed by adverse events (AEs), clinical
safety laboratory assessments, electrocardiograms (ECGs), vital signs and physical
examinations. The total duration of the study is up to 88 weeks (including 4 weeks of
screening).
Details
Condition
Hepatitis B, Chronic
Treatment
Tenofovir disoproxil,
TAF,
JNJ-64300535,
JNJ-73763989,
ETV monohydrate
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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