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A Randomized, Double-blind, Multicenter Study to Determine the Effect of Triheptanoin Compared with Even-chain, Medium-chain Triglycerides (MCT) on Major Clinical Events (MCEs) in Pediatric Patients with Long-chain Fatty Acid Oxidation Disorders (LC-FAOD )

Trial Profile

A Randomized, Double-blind, Multicenter Study to Determine the Effect of Triheptanoin Compared with Even-chain, Medium-chain Triglycerides (MCT) on Major Clinical Events (MCEs) in Pediatric Patients with Long-chain Fatty Acid Oxidation Disorders (LC-FAOD )

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs Triheptanoin (Primary) ; Triheptanoin (Primary) ; Medium-chain triglyceride; Medium-chain triglyceride
  • Indications Lipid metabolism disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Ultragenyx Pharmaceutical

Most Recent Events

  • 25 Feb 2025 Status changed to recruiting.
  • 10 Feb 2025 Planned End Date changed from 1 Sep 2026 to 1 Aug 2027.
  • 10 Feb 2025 Planned primary completion date changed from 1 Sep 2026 to 1 Aug 2027.

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