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Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program (LC-FAOD DMP)

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Trial Profile

Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program (LC-FAOD DMP)

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 29 Nov 2024

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At a glance

  • Drugs Triheptanoin (Primary)
  • Indications Lipid metabolism disorders
  • Focus Adverse reactions
  • Acronyms LC-FAOD DMP
  • Sponsors Ultragenyx Pharmaceutical

    • Most Recent Events

    • 20 Aug 2024 Number of treatment arms are decreased from 5 to 3 by the removal of Triheptanoin Naive Transitioned to Triheptanoin arm and Pregnant unaffected LC-FAOD carrier females arm, thus keeping only 3 cohorts in the study.
    • 20 Aug 2024 Planned number of patients changed from 200 to 150.
    • 15 Jun 2023 Number of treatment cohorts have been increased from 4 to 5 by the addition of Pregnant unaffected LC-FAOD carrier females' cohort- where no intervention is given. Planned patient enrollment has been decreased.

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