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A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Escalation Study to Examine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ISIS 505358 in Treatment-Naïve Patients With Chronic HBV Infection

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Trial Profile

A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Escalation Study to Examine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ISIS 505358 in Treatment-Naïve Patients With Chronic HBV Infection

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Dec 2023

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At a glance

  • Drugs Bepirovirsen (Primary) ; Entecavir; Tenofovir disoproxil fumarate
  • Indications Hepatitis B
  • Focus Adverse reactions
  • Sponsors GlaxoSmithKline; GSK

    • Most Recent Events

    • 14 Nov 2023 Results evaluating patients peripheral blood mononuclear cells (PBMC) post-hoc using deep immunophenotyping by high parameter flow cytometry from this study, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 26 Jun 2022 Results of pooled analysis (Phase 1 study (GSK 213725) in healthy volunteers, Phase 2a (GSK 205695) and Phase 2b (GSK 209668) studies) assessing BPV systemic exposures and effect on changes in HBsAg and ALT and to identify patient characteristics that may be predictors of exposure and response to treatment, presented at The International Liver Congress 2022.
    • 26 Jun 2022 Results of post-hoc analysis evaluating the changes in soluble proteins measured in this study, presented at The International Liver Congress 2022.
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