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Triheptanoin for Children With Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contact updatedv7
  2. Primary completion date: Dec 31, 2026 to Dec 31, 2028
    • Study completion date: Jun 30, 2027 to Jun 30, 2029
    v6
  3. Site contact updatedv5
  4. Start date changed from estimate of Aug 2024 to Jul 11, 2024
    • Site contact updated
    v4
  5. Start date: May 2024 to Aug 2024v3
  6. Start date: Mar 29, 2024 to May 2024v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a medical research study to test a medication in patients with a disease called Pyruvate Dehydrogenase Complex (PDC) Deficiency. The medication is triheptanoin, which is currently FDA approved for the treatment of Long-Chain Fatty Acid Oxidation Disorders. Previous research suggests that triheptanoin may also be effective in the treatment PDC Deficiency. This study will investigate the safety and efficacy (how well it works) of triheptanoin in patients with PDC Deficiency.
Trial Details
NCT Number NCT06340685
Lead Sponsor Jirair Krikor Bedoyan
Collaborators: Ultragenyx Pharmaceutical Inc
Conditions
(from sponsor)		 Pyruvate Dehydrogenase Complex Deficiency
Related terms Pyruvate Dehydrogenase Complex Deficiency Disease
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov