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A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Children and Adolescent Subjects with Chronic Hepatitis B Virus Infection - Tenofovir Alafenamide (TAF) Children and Adolescents

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Trial Profile

A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Children and Adolescent Subjects with Chronic Hepatitis B Virus Infection - Tenofovir Alafenamide (TAF) Children and Adolescents

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Apr 2024

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At a glance

  • Drugs Tenofovir alafenamide (Primary)
  • Indications Hepatitis B
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 28 Mar 2024 According to a Gilead Sciences media release, the U.S. FDA has approved the supplemental NDA for Vemlidy 25mg tablets (once daily) treatment for chronic HBV infection in patients 6 yrs and older & weighing at least 25 kg with compensated liver disease. Approval is supported by Wk 96 data from this trial comparing treatment with Vemlidy 25mg to placebo among 18 treatment-naive and treatment-experienced patients aged 6 to less than 12 yrs weighing at least 25kg (Cohort 2, Group 1).
    • 14 Nov 2023 Results of week 96 (2 year) findings (n=88) assessing the efficacy and safety of Tenofovir Alafenamide in Children and Adolescents with Chronic Hepatitis B, presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 14 Nov 2023 Results of resistance analyses at Week 96 of a Phase 2 study evaluating TAF for the treatment of children and adolescents aged 6 to < 18 years with CHB presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
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