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A Study to Determine the Effect of Triheptanoin Compared With Even-Chain MCT on MCEs in Pediatric Patients With LC-FAOD

NCT05933200 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-04-07

No results posted yet for this study

Summary

The main goal of this study is to evaluate the effects of triheptanoin versus Medium-chain Triglycerides (MCT) on frequency of Major Clinical Events (MCEs).

Conditions

  • Long-chain Fatty Acid Oxidation Disorders (LC-FAOD)

Interventions

DRUG

Triheptanoin

Liquid for oral (PO) or enteral feeding tube administration

DIETARY_SUPPLEMENT

MCT Oil

Liquid for oral (PO) or enteral feeding tube administration

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Ultragenyx Pharmaceutical Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Czechia
  • Germany
  • Japan
  • Poland
  • Saudi Arabia
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933200 on ClinicalTrials.gov