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Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program
NCT04632953 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to assess the long-term safety, including pregnancy, infant, and lactation outcomes, of patients with LC-FAOD who are enrolled in the DMP.
Conditions Studied
Interventions
- OTHER No Intervention
Study Locations (16)
Ontario
- CHEO (Children's Hospital Eastern Ontario) — Ottawa
- SickKids (The Hospital for Sick Children) — Toronto
Arizona
- Phoenix Children's Hospital — Phoenix
California
- University of California San Francisco — San Francisco
Colorado
- Children's Hospital of Colorado — Aurora
Florida
- University of South Florida — Tampa
Georgia
- The Emory Clinic — Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital — Chicago
Massachusetts
- Boston Children's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2035-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04632953
The ClinicalTrials.gov registry entry for NCT04632953 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ultragenyx Pharmaceutical, which has 23 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Long-chain Fatty Acid Oxidation Disorders (LC-FAOD) appearing as the primary indexed condition, and to 1 intervention — of which No Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04632953 reports 16 study locations spanning 15 distinct geographic areas — top geographies include Ontario, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04632953 about?
NCT04632953 is a clinical study titled "Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program". The primary objective of this study is to assess the long-term safety, including pregnancy, infant, and lactation outcomes, of patients with LC-FAOD who are enrolled in the DMP.
What is the current status of trial NCT04632953?
This trial is currently active not recruiting. The enrollment target is 150 participants. The study started on 2021-11-30. Estimated completion is 2035-12.
What conditions does trial NCT04632953 study?
This clinical trial studies the following conditions: Long-chain Fatty Acid Oxidation Disorders (LC-FAOD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04632953?
The interventions under investigation include: No Intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04632953?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04632953 being conducted?
This trial has 16 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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