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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: Completed Phase 2 study of Fabry Disease, sponsored by Shire.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01363492 record still lists
NCT01363492 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (97% lower).
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 lists 5 locations in 5 states (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
Similar trials for Fabry Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01363492's enrollment target sits among peer trials
15 26th of 32 higher than 7 of 32 other Fabry Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fabry Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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