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NCT01886378 · ClinicalTrials.gov registry record · Phase 2
A Study of UX007 (Triheptanoin) in Participants With Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)
A Phase 2 study of Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) and Carnitine Palmitoyltransferase (CPT II) Deficiency, sponsored by Ultragenyx Pharmaceutical.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 10
- Study locations
NCT01886378 is a Phase 2 study of Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) and Carnitine Palmitoyltransferase (CPT II) Deficiency that has completed, run by Ultragenyx Pharmaceutical. The registered enrollment target is 29 participants. The trial reports 10 study locations across 8 states.
The verdict
NCT01886378, a Phase 2 study of Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) and Carnitine Palmitoyltransferase (CPT II) Deficiency, has completed, sponsored by Ultragenyx Pharmaceutical.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective of the study was to evaluate the impact of UX007 on acute clinical pathophysiology associated with LC-FAOD following 24 weeks of treatment.
Conditions Studied
Interventions
- DRUG UX007
Study Locations (10)
Other
- Birmingham Children's Hospital - Birmingham
- National Hospital for Neurology and Neurosurgery - London
- Great Ormond Street Hospital - London
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of Southern Florida - Tampa
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Tennessee
- Vanderbilt Medical Center - Nashville
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-02-06 |
| Est. Completion | 2016-08-25 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01886378
The ClinicalTrials.gov registry entry for NCT01886378 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ultragenyx Pharmaceutical, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) appearing as the primary indexed condition, and to 1 intervention - of which UX007 is the first listed.
NCT01886378 reports 10 study locations spanning 8 distinct geographic areas - top geographies include Other, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT01886378 about?
NCT01886378 is a clinical study titled "A Study of UX007 (Triheptanoin) in Participants With Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)". The primary objective of the study was to evaluate the impact of UX007 on acute clinical pathophysiology associated with LC-FAOD following 24 weeks of treatment.
What is the current status of trial NCT01886378?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2014-02-06. Estimated completion is 2016-08-25.
What conditions does trial NCT01886378 study?
This clinical trial studies the following conditions: Long-chain Fatty Acid Oxidation Disorders (LC-FAOD), Carnitine Palmitoyltransferase (CPT II) Deficiency, Very Long Chain Acyl-CoA Dehydrogenase (VLCAD) Deficiency, Longchain 3-hydroxy-acyl-CoA Dehydrogenase (LCHAD) Deficiency, Trifunctional Protein (TFP) Deficiency.
What interventions are being tested in trial NCT01886378?
The interventions under investigation include: UX007 (DRUG).
Who is sponsoring clinical trial NCT01886378?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01886378 being conducted?
This trial has 10 study locations across District of Columbia, Florida, Illinois, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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