Long Term Follow Up to Evaluate DTX301 in Adults With Late-Onset OTC Deficiency
Public ClinicalTrials.gov record NCT03636438. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Long-Term Follow-up Study to Evaluate Safety and Efficacy of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults With Late-Onset OTC Deficiency
Study identification
- NCT ID
- NCT03636438
- Recruitment status
- Active, not recruiting
- Study type
- Observational
- Phase
- Not listed
- Lead sponsor
- Ultragenyx Pharmaceutical Inc
- Industry
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Interventions
- No Intervention Other
Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 29, 2018
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2029
- Last update posted
- Feb 18, 2026
2018 – 2029
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Icahn School of Medicine | New York | New York | 10029 | — |
| University Hospital Cleveland Medical Center/Case Western Reserve University | Cleveland | Ohio | 44106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03636438, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 18, 2026 · Synced May 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03636438 live on ClinicalTrials.gov.