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NCT01124643 · ClinicalTrials.gov registry record · Phase 3
Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease
A Phase 3 study of Fabry Disease, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
- 9
- Study locations
NCT01124643: Completed Phase 3 study of Fabry Disease, sponsored by Shire.
NCT01124643 is a Phase 3 study of Fabry Disease that has completed, run by Shire. The registered enrollment target is 35 participants, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (94% lower). The trial reports 9 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124643, a Phase 3 study of Fabry Disease, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
- 9
- Study locations
Study Summary
This study will evaluate safety and clinical outcomes of treatment with Replagal in adult participants with Fabry disease who have completed Study TKT028 (NCT00864851).
Conditions Studied
Interventions
- BIOLOGICAL Replagal
Study Locations (9)
Other
- The Royal Melbourne Hospital - Parkville
- 1st School of Medicine Charles University - Prague
- Turku University Central Hospital - Turku
- Szpital Uniwersytecki w Krakowie - Krakow
- Instytut Kardiologii, I Klinika Choroby Wiencowej - Warsaw
- General Hospital Slovenj Gradec - Slovenj Gradec
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Virginia
- O&O Alpan LLC - Fairfax
England
- Salford Royal NHS Foundation Trust - Salford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2010-04-13 |
| Est. Completion | 2013-07-08 |
| Phase | Phase 3 |
What the finished NCT01124643 record still lists
NCT01124643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 1 intervention - of which Replagal is the first listed.
NCT01124643 lists 9 locations in 4 states (Other, Iowa, Virginia).
Frequently Asked Questions
What is clinical trial NCT01124643 about?
NCT01124643 is a clinical study titled "Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease". This study will evaluate safety and clinical outcomes of treatment with Replagal in adult participants with Fabry disease who have completed Study TKT028 (NCT00864851).
What is the current status of trial NCT01124643?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2010-04-13. Estimated completion is 2013-07-08.
What conditions does trial NCT01124643 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT01124643?
The interventions under investigation include: Replagal (BIOLOGICAL).
Who is sponsoring clinical trial NCT01124643?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01124643 being conducted?
This trial has 9 study locations across Iowa, Virginia, England. 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 NCT01124643's enrollment target sits among peer trials
35 15th of 32 higher than 18 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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