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NCT03614234 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients
A Phase 3 study of Fabry Disease, sponsored by Chiesi Farmaceutici S.p.A..
- Active
- Registry status
- Phase 3
- Development phase
- 29
- Enrollment target
- 14
- Study locations
NCT03614234: Active Phase 3 study of Fabry Disease, sponsored by Chiesi Farmaceutici S.p.A..
NCT03614234 is a Phase 3 study of Fabry Disease that is active but no longer recruiting, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 29 participants, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03614234, a Phase 3 study of Fabry Disease, is active but no longer recruiting, sponsored by Chiesi Farmaceutici S.p.A..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 29 participants
- Enrollment target
- 14
- Study locations
Study Summary
The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have successfully completed PB-102-F50.
Primary Outcome
CTCAE v4.03
Conditions Studied
Interventions
- DRUG pegunigalsidase alfa
Study Locations (14)
Other
- UZ Antwerpen - Edegem
- Fakultní poliklinika Všeobecné fakultní nemocnice v Praze - Prague
- Medical Endocrinology PE 2132, Rigshospitalet - Copenhagen
- Helse Bergen HF Haukeland Universitetssykehus - Bergen
- Addenbrooke's Hospital - Cambridge
- The Royal Free Hospital - London
Alabama
- UAB Medicine - Birmingham
Georgia
- Emory University School of Medicine - Atlanta
Iowa
- University of Iowa Hospitals and Clinica - Iowa City
Michigan
- Infusion Associates - Grand Rapids
Texas
- Renal Disease Research Institute, LLC - Dallas
Utah
- University of Utah Hospitals & Clinics - Salt Lake City
Virginia
- O & O Alpan - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-11-13 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT03614234 still lists
NCT03614234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (95% 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.
NCT03614234 lists 14 locations in 9 states (Other, Alabama, Georgia).
Frequently Asked Questions
What is clinical trial NCT03614234 about?
NCT03614234 is a clinical study titled "Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients". The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have successfully completed PB-102-F50.
What is the current status of trial NCT03614234?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 29 participants. The study started on 2018-11-13. Estimated completion is 2026-06-30.
What conditions does trial NCT03614234 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT03614234?
The interventions under investigation include: pegunigalsidase alfa (DRUG).
Who is sponsoring clinical trial NCT03614234?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03614234 being conducted?
This trial has 14 study locations across Alabama, Georgia, Iowa, Michigan, Texas. 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 NCT03614234's enrollment target sits among peer trials
29 17th of 32 higher than 16 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
-
A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA Variants
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A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease
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Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
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