NCT03566017CompletedPhase 3
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who had successfully completed studies PB-102-F20, PB-102-F30, or at least 48 months in study PB-102-F03.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 97 (actual)
- First submitted
- 24 May 2018
- Start date
- 16 Sept 2018
- Primary completion date
- 21 Jan 2025
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Diseases
- Fabry disease
- NCT number
- NCT03566017
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 97
- From 16 Sept 2018 to the primary completion date, 21 Jan 2025
- 30 sites in 13 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, not your situation.
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-F20, study PB-102-F30, or at least 48 months in study PB-102-F03.
- The participant signed informed consent.
- Female participants and male participants whose co-partners were of child-bearing potential agreed to use a medically acceptable method of contraception. These included 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, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. Contraception had to be used for 2 weeks after treatment termination.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Capital District Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Hospital de Dia Quiron Zaragoza Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Turku University Central Hospital Coordinator of this site? Confirm its status | Turku | Finland | Unknown status |
| Hospital Raymond-Poincaré Coordinator of this site? Confirm its status | Garches | France | Unknown status |
| Addenbrooke's Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Edgbaston | United Kingdom | Unknown status |
| The Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Salford Royal Coordinator of this site? Confirm its status | Salford | United Kingdom | Unknown status |
| Semmelweis Egyetem Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Academisch Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Haukeland University Hospital Klinisk Forskningspost Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
| General Hospital Slovenj Gradec Coordinator of this site? Confirm its status | Slovenj Gradec | Slovenia | Unknown status |
| 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 |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Institute of Metabolic Disease Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Renal Disease Research Institute, LLC - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| O+O Alpan LLC Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Infusion Associates Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of California Irvine Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Utah Hospitals & Clinics Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.