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A Phase 3, Parallel-Group Treatment, Blinded, Randomized, Placebo-Controlled Study To Assess The Efficacy And Safety Of Pegtibatinase Administered Subcutaneously In Addition To Standard Of Care In Participants With Classical Homocystinuria Due To Cystathionine Beta Synthase Deficiency (HARMONY).

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Trial Profile

A Phase 3, Parallel-Group Treatment, Blinded, Randomized, Placebo-Controlled Study To Assess The Efficacy And Safety Of Pegtibatinase Administered Subcutaneously In Addition To Standard Of Care In Participants With Classical Homocystinuria Due To Cystathionine Beta Synthase Deficiency (HARMONY).

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2025

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At a glance

  • Drugs Pegtibatinase (Primary)
  • Indications Homocystinuria
  • Focus Registrational; Therapeutic Use
  • Acronyms HARMONY
  • Sponsors Travere Therapeutics

Most Recent Events

  • 20 Feb 2025 According to a Travere Therapeutics media release, company is on track to restart enrollment in the Phase 3 HARMONY Study in 2026.
  • 26 Sep 2024 event According to a Travere Therapeutics media release, status changed from recruiting to active, no longer recruiting.
  • 26 Sep 2024 According to a Travere Therapeutics media release, company announced a voluntary pause of enrollment in the trial, this pause enables the Company to work to address necessary process improvements in manufacturing scale-up to support commercial scale manufacturing as well as full enrollment in the HARMONY Study. And expects restart enrollment in 2026.

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