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A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (REEF-1)
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......https://clinicaltrials.gov/ct2/show/NCT03982186
Detailed Description:
A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection. 450 participants. August 1, 2019
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 ribonucleic acid interference mechanism. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate efficacy as measured by proportion of participants who completed 48-week study intervention and qualified for stopping NA treatment at Week 48. The study includes: Screening phase (4 weeks), Double-blind study intervention phase (from Day 1 up to Week 48), and Follow-up phase (48 weeks after end of investigational intervention with a maximum duration of 96 weeks). The duration of individual study participation will be between 100 and 150 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HBsAg seroclearance), and pharmacokinetics will be assessed throughout the study.
EASL: Short term RNA interference (RNAi) therapy in chronic hepatitis B (CHB) using JNJ-3989 brings majority of patients to HBsAg <100 IU/ml threshold - (04/19/19)
EASL: Development of subcutaneously administered RNAi therapeutic ARO-HBV for chronic hepatitis B virus infection - (04/30/18)
First results with RNA interference (RNAi) in chronic hepatitis B (CHB) using ARO-HBV - (02/13/19)
EASL/2018: RNA interference therapy with ARC-520 Injection results in long term off-therapy antigen reductions in treatment naïve, HBeAgpositive and negative patients with chronic HBV - (04/30/18)
Phase II, dose ranging study of ARC-520, a siRNA-based therapeutic, in patients with chronic hepatitis B virus infection......http://www.natap.org/2014/AASLD/AASLD_153.htm
EASL: Safety, Pharmacokinetics and Antiviral Activity of Novel HBV Capsid Assembly Modulator, JNJ-56136379, in Non-cirrhotic, Treatment-naïve Patients with Chronic Hepatitis B - (04/18/18)
APASL: Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of JNJ-56136379, a Novel HBV Capsid Assembly Modulator, in Japanese Adult Healthy Volunteers - (03/22/18)
EASL: Safety, Antiviral Activity, and Pharmacokinetics of a Novel Hepatitis B Virus Capsid Assembly Modulator, JNJ-56136379, in Asian and Caucasian Patients with Chronic Hepatitis B - (04/29/19)
EASL: HBcrAg Decline in JNJ-56136379-treated Chronic Hepatitis B Patients: Results of a Phase 1 Study - (04/29/19)
http://www.natap.org/hbv.htm
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