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NCT01363492 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Replagal® Therapy in Children With Fabry Disease
A Phase 2 study of Fabry Disease, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 5
- Study locations
NCT01363492 is a Phase 2 study of Fabry Disease that has completed, run by Shire. The registered enrollment target is 15 participants, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (97% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT01363492, a Phase 2 study of Fabry Disease, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to assess the safety of Replagal in children with Fabry disease who who have not previously been treated with enzyme replacement therapy (ERT).
Conditions Studied
Interventions
- BIOLOGICAL Replagal (agalsidase alfa)
Study Locations (5)
Georgia
- Emory Division of Medical Genetics - Decatur
North Carolina
- Duke University Medical Center - Durham
Texas
- Baylor University Medical Center - Dallas
Utah
- University of Utah Hospital - Salt Lake City
Virginia
- O & O Alpan LLC - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2011-05-12 |
| Est. Completion | 2013-04-17 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01363492
The ClinicalTrials.gov registry entry for NCT01363492 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (97% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 1 intervention - of which Replagal (agalsidase alfa) is the first listed.
NCT01363492 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Georgia, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT01363492 about?
NCT01363492 is a clinical study titled "Safety Study of Replagal® Therapy in Children With Fabry Disease". The purpose of this study is to assess the safety of Replagal in children with Fabry disease who who have not previously been treated with enzyme replacement therapy (ERT).
What is the current status of trial NCT01363492?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2011-05-12. Estimated completion is 2013-04-17.
What conditions does trial NCT01363492 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT01363492?
The interventions under investigation include: Replagal (agalsidase alfa) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01363492?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01363492 being conducted?
This trial has 5 study locations across Georgia, North Carolina, Texas, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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