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A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) Given in Combination With an Individualized Rifampin-Resistant Tuberculosis (RR-TB) Therapy in Infants, Children, and Adolescents With RR-TB Disease, Living With or Without HIV

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Trial Profile

A Phase I/II, Open-Label, Single Arm Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Bedaquiline (BDQ) Given in Combination With an Individualized Rifampin-Resistant Tuberculosis (RR-TB) Therapy in Infants, Children, and Adolescents With RR-TB Disease, Living With or Without HIV

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 21 May 2024

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At a glance

  • Drugs Bedaquiline (Primary)
  • Indications Tuberculosis
  • Focus Adverse reactions; Pharmacokinetics

    • Most Recent Events

    • 16 Feb 2024 Status changed from recruiting to active, no longer recruiting.
    • 25 Sep 2023 Planned number of patients changed from 72 to 84, Primary endpoints has been amended and trial focus has now shifted to Ar and Pk.
    • 25 Sep 2023 Planned End Date changed from 1 Jun 2024 to 15 Aug 2025.

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