A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease
Public ClinicalTrials.gov record NCT03737214. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-center, Open-label, Uncontrolled, Single-arm, Extension Study to Determine the Long-term Safety and Tolerability of Oral Lucerastat in Adult Subjects With Fabry Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03737214
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 107 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 17, 2018
- Primary completion
- Jul 31, 2029
- Completion
- Oct 31, 2029
- Last update posted
- Aug 30, 2026
2018 – 2029
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham - Nephrology Research Clinic | Birmingham | Alabama | 35294 | — |
| University of California Irvine | Irvine | California | 92697 | — |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | — |
| University of Florida Clinical and Translational Science Institute, UF Clinical Research Center | Gainesville | Florida | 32610 | — |
| Rush University Medical Center - Dept of Pediatrics | Chicago | Illinois | 60612 | — |
| University of Iowa Stead Family Children's Hospital - Division of Medical Genetics | Iowa City | Iowa | 52242 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Infusion Associates | Grand Rapids | Michigan | 49525 | — |
| University of Pennsylvania - Dept of Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Greenwood Genetics Center | Greenville | South Carolina | 29605 | — |
| Renal Disease Research Institute LLC | Dallas | Texas | 75204 | — |
| Baylore University Medical Center | Dallas | Texas | 75246 | — |
| University of Utah - Division of Medical Genetics, Clinical Genetics Research | Salt Lake City | Utah | 84108 | — |
| Lysosomal and Rare Disorders Research and Treatment Center, Inc. | Fairfax | Virginia | 22030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03737214, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03737214 live on ClinicalTrials.gov.