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NCT03636438 · ClinicalTrials.gov registry record
Long Term Follow Up to Evaluate DTX301 in Adults With Late-Onset OTC Deficiency
A clinical trial of Ornithine Transcarbamylase (OTC) Deficiency, sponsored by Ultragenyx Pharmaceutical.
- Active
- Registry status
- 11
- Enrollment target
- 9
- Study locations
NCT03636438: Active study of Ornithine Transcarbamylase (OTC) Deficiency, sponsored by Ultragenyx Pharmaceutical.
NCT03636438 is a study of Ornithine Transcarbamylase (OTC) Deficiency that is active but no longer recruiting, run by Ultragenyx Pharmaceutical. The registered enrollment target is 11 participants. The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03636438, a study of Ornithine Transcarbamylase (OTC) Deficiency, is active but no longer recruiting, sponsored by Ultragenyx Pharmaceutical.
- ACTIVE NOT RECRUITING
- Registry status
- 11 participants
- Enrollment target
- 9
- Study locations
Study Summary
Determine the long-term safety of DTX301 following a single intravenous (IV) dose in adults with late-onset ornithine transcarbamylase (OTC) deficiency.
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (9)
Colorado
- The Children's Hospital Colorado - Aurora
Massachusetts
- Boston Children's Hospital - Boston
New York
- Icahn School of Medicine - New York
Ohio
- University Hospital Cleveland Medical Center/Case Western Reserve University - Cleveland
Alberta
- M.A.G.I.C. Clinic - Calgary
Rhone
- Hopital Femme Mere Enfant - Bron
Coruna
- Hospital Clinico Universitario de Santiago - Santiago de Compostela
Vizcaya
- Hospital Universitario de Cruces. Servicio de Pediatria - Barakaldo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-08-30 |
| Est. Completion | 2029-12 |
What the registry record for NCT03636438 still lists
NCT03636438 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 1 condition, with Ornithine Transcarbamylase (OTC) Deficiency appearing as the primary indexed condition, and to 1 intervention - of which No Intervention is the first listed.
NCT03636438 lists 9 locations in 9 states (Colorado, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT03636438 about?
NCT03636438 is a clinical study titled "Long Term Follow Up to Evaluate DTX301 in Adults With Late-Onset OTC Deficiency". Determine the long-term safety of DTX301 following a single intravenous (IV) dose in adults with late-onset ornithine transcarbamylase (OTC) deficiency.
What is the current status of trial NCT03636438?
This trial is currently active not recruiting. The enrollment target is 11 participants. The study started on 2018-08-30. Estimated completion is 2029-12.
What conditions does trial NCT03636438 study?
This clinical trial studies the following conditions: Ornithine Transcarbamylase (OTC) Deficiency.
What interventions are being tested in trial NCT03636438?
The interventions under investigation include: No Intervention (OTHER).
Who is sponsoring clinical trial NCT03636438?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03636438 being conducted?
This trial has 9 study locations across Colorado, Massachusetts, New York, Ohio, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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