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NCT04020055 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease
A Phase 3 study of Fabry Disease, sponsored by Amicus Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 14
- Enrollment target
- 12
- Study locations
NCT04020055 is a Phase 3 study of Fabry Disease that is active but no longer recruiting, run by Amicus Therapeutics. The registered enrollment target is 14 participants, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (97% lower). The trial reports 12 study locations across 9 states.
The verdict
NCT04020055, a Phase 3 study of Fabry Disease, is active but no longer recruiting, sponsored by Amicus Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 14 participants
- Enrollment target
- 12
- Study locations
Study Summary
An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)
Conditions Studied
Interventions
- DRUG migalastat HCl 150 mg
Study Locations (12)
Other
- Centro Hospitalar e Universitário de Coimbra (CHUC) - Coimbra
- Hospital Universitari(o) de Bellvitge (HUB) Feixa Llarga - Barcelona
- Hospital General Universitario de Elda - Elda
- Hospital General Universitario Gregorio Marañon - Madrid
Georgia
- Emory University - Atlanta
Ohio
- The Cleveland Clinic - Cleveland
Virginia
- Lysosomal and Rare Disorders Research and Treatment Center, Inc - Fairfax
Victoria
- Royal Melbourne Hospital - Parkville
Washington
- Royal Perth Hospital - Perth
Osaka
- Osaka University Hospital - Suita
Shizuoka
- Shizuoka General Hospital - Shizuoka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04020055
The ClinicalTrials.gov registry entry for NCT04020055 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 14 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 (97% lower). The listed sponsor is Amicus Therapeutics, 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 migalastat HCl 150 mg is the first listed.
NCT04020055 reports 12 study locations spanning 9 distinct geographic areas - top geographies include Other, Georgia, Ohio.
Frequently Asked Questions
What is clinical trial NCT04020055 about?
NCT04020055 is a clinical study titled "A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease". An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)
What is the current status of trial NCT04020055?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2022-10-31. Estimated completion is 2026-12-31.
What conditions does trial NCT04020055 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT04020055?
The interventions under investigation include: migalastat HCl 150 mg (DRUG).
Who is sponsoring clinical trial NCT04020055?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04020055 being conducted?
This trial has 12 study locations across Georgia, Ohio, Virginia, Victoria, Washington. 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
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