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NCT06663358 · ClinicalTrials.gov registry record
A Multi-Country Observational Study of Safety and Effectiveness of Elfabrio® in Fabry Patients
A clinical trial of Fabry Disease, sponsored by Chiesi Farmaceutici S.p.A..
- Recruiting
- Registry status
- 100
- Enrollment target
- 10
- Study locations
NCT06663358: Recruiting study of Fabry Disease, sponsored by Chiesi Farmaceutici S.p.A..
NCT06663358 is a study of Fabry Disease that is actively recruiting participants, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 100 participants, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (81% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06663358, a study of Fabry Disease, is actively recruiting participants, sponsored by Chiesi Farmaceutici S.p.A..
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 10
- Study locations
Study Summary
A multi-centre, multi-country, observational, non-interventional, retrospective and prospective (hybrid) study among Fabry disease participants treated with pegunigalsidase alfa (Elfabrio®) in routine clinical care.
Primary Outcome
eGFR, calculated using the Chronic Kidney Disease - Epidemiology Collaboration (eGFRCKD-EPI) equation from study baseline and from pegunigalsidase alfa treatment start to end of follow-up and to pre-specified time points (annually).
Conditions Studied
Interventions
- DRUG Pegunigalsidase-alfa
Study Locations (10)
Other
- General Hospital Slovenj Gradec - Slovenj Gradec
- The Royal Free Hospital - London
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Emory University School of Medicine - Atlanta
Illinois
- Northwestern University - Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Michigan
- Infusion Associates - Grand Rapids
Virginia
- Lysosomal & Rare Disorder Research & Treatment Center (LRDRTC) - Fairfax
Birmingham
- University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital - Edgbaston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-11-06 |
| Est. Completion | 2029-11 |
What NCT06663358 shows while recruiting
NCT06663358 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 1 intervention - of which Pegunigalsidase-alfa is the first listed.
NCT06663358 lists 10 locations in 9 states (Other, Alabama, Georgia).
Frequently Asked Questions
What is clinical trial NCT06663358 about?
NCT06663358 is a clinical study titled "A Multi-Country Observational Study of Safety and Effectiveness of Elfabrio® in Fabry Patients". A multi-centre, multi-country, observational, non-interventional, retrospective and prospective (hybrid) study among Fabry disease participants treated with pegunigalsidase alfa (Elfabrio®) in routine clinical care.
What is the current status of trial NCT06663358?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2024-11-06. Estimated completion is 2029-11.
What conditions does trial NCT06663358 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT06663358?
The interventions under investigation include: Pegunigalsidase-alfa (DRUG).
Who is sponsoring clinical trial NCT06663358?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06663358 being conducted?
This trial has 10 study locations across Alabama, Georgia, Illinois, Iowa, Michigan. 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 NCT06663358's enrollment target sits among peer trials
100 9th of 32 higher than 24 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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