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A Phase 3b Single Arm Clinical Study to Evaluate the Efficacy and Safety of MT1621 in Nucleos(t)Ide Treatment Naïve Pediatric and Adolescent Subjects With Thymidine Kinase 2 (TK2) Deficiency

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Trial Profile

A Phase 3b Single Arm Clinical Study to Evaluate the Efficacy and Safety of MT1621 in Nucleos(t)Ide Treatment Naïve Pediatric and Adolescent Subjects With Thymidine Kinase 2 (TK2) Deficiency

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs Deoxycytidine/deoxythymidine (Primary)
  • Indications Mitochondrial disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Modis Therapeutics
  • Most Recent Events

    • 29 Aug 2023 Planned End Date changed from 1 Apr 2025 to 30 Apr 2025.
    • 29 Aug 2023 Planned primary completion date changed from 1 Mar 2025 to 31 Mar 2025.
    • 29 Aug 2023 Planned initiation date changed from 1 Sep 2022 to 30 Sep 2022.
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