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A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With 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

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Trial Profile

A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With 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: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Feb 2025

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At a glance

  • Drugs Bersacapavir (Primary) ; JNJ 73763989 (Primary) ; Entecavir; Tenofovir alafenamide; Tenofovir dipivoxil fumarate
  • Indications Hepatitis B
  • Focus Therapeutic Use
  • Acronyms REEF-2
  • Sponsors Janssen Research & Development; Janssen Sciences Ireland UC

Most Recent Events

  • 24 Jun 2023 Results of exploratory analysis assessing association of post-treatment virologic relapse and biochemical flares with HBV serum biomarkers in long-term virologically suppressed HBeAg-negative patients stopping NA treatment, presented at the European Association for the Study of the Liver Congress 2023.
  • 24 Jun 2023 Results using data from the global phase 2b REEF-1 and REEF-2 trials , assessing self-stigma in people with CHB using content and psychometric validation of a new patient-reported outcome instrument, presented at the European Association for the Study of the Liver Congress 2023
  • 08 Nov 2022 Primary endpoint (Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 (24 weeks after completion of all study interventions at Week 48) Without Restarting NA Treatment) has not been met, as per results presented at The Liver Meeting 2022: 73rd Annual Meeting of the American Association for the Study of Liver Diseases.

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