NCT03614234CompletedPhase 3
Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients
Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 30 Jul 2018
- Start date
- 13 Nov 2018
- Primary completion date
- 13 Apr 2026
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Diseases
- Fabry disease
- NCT number
- NCT03614234
- EU CT number
- 2024-516735-27-00
- EudraCT number
- 2018-001947-30
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 29
- From 13 Nov 2018 to the primary completion date, 13 Apr 2026
- 14 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Presence of any medical, emotional, behavioral, or psychological condition that, in the judgment of the Investigator, would interfere with patient compliance with the requirements of the study.
Who the study is looking for
- Completion of study PB-102-F50.
- The patient signs informed consent.
- Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically accepted, effective contraception method. These include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) supplemented with a barrier method (preferably male condom), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) supplemented with a barrier method (preferably male condom), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. Contraception should be used for 2 weeks after treatment termination.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Antwerp Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| The Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Completed |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Uab Medicine Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Renal Disease Research Institute, LLC Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| O & O Alpan Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| Infusion Associates Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| University of Iowa Hospitals and Clinica Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Utah Hospitals & Clinics Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.