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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03614234
The ClinicalTrials.gov registry entry for NCT03614234 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 29 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 (95% lower). The listed sponsor is Chiesi Farmaceutici S.p.A., which has 30 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 pegunigalsidase alfa is the first listed.
NCT03614234 reports 14 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
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.