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Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)

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Trial Profile

Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Aug 2024

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At a glance

  • Drugs Bepirovirsen (Primary) ; Nucleoside reverse transcriptase inhibitors; Nucleotide reverse transcriptase inhibitors
  • Indications Hepatitis B
  • Focus Therapeutic Use
  • Acronyms B-Clear
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

    • Most Recent Events

    • 29 Feb 2024 According to GSK media release, US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, based on data from the phase IIb trials B-Clear and B-Sure
    • 14 Nov 2023 Results of post-hoc analysis assessing the association of BPV binding site single nucleotide polymorphism (SNP) detected in post-baseline samples and the impact on end of tmt (EOT) and end of study (EOS) hepatitis B surface antigen (HBsAg) serum level reduction, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 14 Nov 2023 Results of post hoc analysis assessing the protein expression according to HBsAg response and presence of ALT increase in the first 12 weeks of treatment, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.

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