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NCT03737214 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease
A Phase 3 study of Fabry Disease, sponsored by Idorsia Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT03737214 is a Phase 3 study of Fabry Disease that is active but no longer recruiting, run by Idorsia Pharmaceuticals. The registered enrollment target is 107 participants, below the 539-participant average among 32 other Fabry Disease trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT03737214, a Phase 3 study of Fabry Disease, is active but no longer recruiting, sponsored by Idorsia Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
Study Summary
A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease. This study includes a sub-study evaluating kidney Gb3 inclusions (and other histologic lesions) in male participants with classic Fabry disease who have been treated for at least 2 years with lucerastat monotherapy in study ID-069A302.
Conditions Studied
Interventions
- DRUG Lucerastat
Study Locations (20)
Other
- Royal Melbourne Hospital - Department of Nephrology - Parkville
- Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse - Vienna
- University Hospital Ghent (UZ Ghent) - Ghent
- University Hospital Gasthuisberg, Leuven (UZ Leuven) - Leuven
- University of Calgary - Heritage Medical Research Clinic - Calgary
California
- University of California Irvine - Irvine
- UCSF Benioff Children's Hospital Oakland - Oakland
Texas
- Renal Disease Research Institute LLC - Dallas
- Baylore University Medical Center - Dallas
Alabama
- University of Alabama at Birmingham - Nephrology Research Clinic - Birmingham
Florida
- University of Florida Clinical and Translational Science Institute, UF Clinical Research Center - Gainesville
Illinois
- Rush University Medical Center - Dept of Pediatrics - Chicago
Iowa
- University of Iowa Stead Family Children's Hospital - Division of Medical Genetics - Iowa City
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2029-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03737214
The ClinicalTrials.gov registry entry for NCT03737214 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 539-participant average among 32 other Fabry Disease trials with a reported enrollment target (80% lower). The listed sponsor is Idorsia Pharmaceuticals, which has 34 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 Lucerastat is the first listed.
NCT03737214 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT03737214 about?
NCT03737214 is a clinical study titled "A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease". A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease. This study includes a sub-study evaluating kidney Gb3 inclusions (and other histologic lesions) in male participants with classic Fabry disease who have been treated for at least 2 yea...
What is the current status of trial NCT03737214?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2018-12-18. Estimated completion is 2029-11.
What conditions does trial NCT03737214 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT03737214?
The interventions under investigation include: Lucerastat (DRUG).
Who is sponsoring clinical trial NCT03737214?
This trial is sponsored by Idorsia Pharmaceuticals, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03737214 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.