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NCT03651505 · ClinicalTrials.gov registry record
X-linked Hypophosphatemia Disease Monitoring Program
A clinical trial of X-linked Hypophosphatemia and Hypophosphatemic Rickets, sponsored by Ultragenyx Pharmaceutical.
- Active
- Registry status
- 782
- Enrollment target
- 20
- Study locations
NCT03651505: Active study of X-linked Hypophosphatemia and Hypophosphatemic Rickets, sponsored by Ultragenyx Pharmaceutical.
NCT03651505 is a study of X-linked Hypophosphatemia and Hypophosphatemic Rickets that is active but no longer recruiting, run by Ultragenyx Pharmaceutical. The registered enrollment target is 782 participants, above the 18-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (4244% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03651505, a study of X-linked Hypophosphatemia and Hypophosphatemic Rickets, is active but no longer recruiting, sponsored by Ultragenyx Pharmaceutical.
- ACTIVE NOT RECRUITING
- Registry status
- 782 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objectives of this observational study are to characterize XLH disease presentation and progression and to assess long-term effectiveness and safety of burosumab.
Primary Outcome
To assess the long-term safety of burosumab treatment in adult and pediatric patients with XLH, including overall renal health, the presence and/or progression of nephrocalcinosis and spinal stenosis, and pregnancy outcomes.
Conditions Studied
Interventions
- OTHER No intervention
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Rady Children's Hospital San Diego - San Diego
- University of California San Francisco - San Francisco
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Nationwide Children's Hospital - Columbus
- The Ohio State University Wexner Medical Center - Columbus
Tennessee
- Vanderbilt University - Department of Medicine - Nashville
- Vanderbilt University - Department of Pediatrics - Nashville
Texas
- Houston Methodist Research Institute - Houston
- University of Texas, Health Science Center - Houston
Alabama
- Children's Hospital of Alabama - Birmingham
Colorado
- Children's Hospital of Colorado - Aurora
Connecticut
- Yale University School of Medicine - New Haven
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 782 participants |
| Start Date | 2018-07-16 |
| Est. Completion | 2032-12 |
What the registry record for NCT03651505 still lists
NCT03651505 is an observational study that tracks outcomes without assigning an intervention. The registered 782 participants enrollment target is mid-sized for trials with a published cap, above the 18-participant average among 5 other X-linked Hypophosphatemia trials with a reported enrollment target (4244% higher).
The record links to 2 conditions, with X-linked Hypophosphatemia appearing as the primary indexed condition, and to 1 intervention - of which No intervention is the first listed.
NCT03651505 names 20 study sites across 14 states, led by California, Ohio, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03651505 about?
NCT03651505 is a clinical study titled "X-linked Hypophosphatemia Disease Monitoring Program". The objectives of this observational study are to characterize XLH disease presentation and progression and to assess long-term effectiveness and safety of burosumab.
What is the current status of trial NCT03651505?
This trial is currently active not recruiting. The enrollment target is 782 participants. The study started on 2018-07-16. Estimated completion is 2032-12.
What conditions does trial NCT03651505 study?
This clinical trial studies the following conditions: X-linked Hypophosphatemia, Hypophosphatemic Rickets.
What interventions are being tested in trial NCT03651505?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT03651505?
This trial is sponsored by Ultragenyx Pharmaceutical, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03651505 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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