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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01124643
The ClinicalTrials.gov registry entry for NCT01124643 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 35 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 (94% 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 is the first listed.
NCT01124643 reports 9 study locations spanning 4 distinct geographic areas - top geographies include 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
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.