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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.
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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
Capital District Health Authority
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HalifaxCanadaUnknown status
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaUnknown status
Hospital de Dia Quiron Zaragoza
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ZaragozaSpainUnknown status
Turku University Central Hospital
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TurkuFinlandUnknown status
Hospital Raymond-Poincaré
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GarchesFranceUnknown status
Addenbrooke's Hospital
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CambridgeUnited KingdomUnknown status
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
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EdgbastonUnited KingdomUnknown status
The Royal Free Hospital
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LondonUnited KingdomUnknown status
Salford Royal
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SalfordUnited KingdomUnknown status
Semmelweis Egyetem
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BudapestHungaryUnknown status
Azienda Ospedaliera Universitaria Federico II
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NaplesItalyUnknown status
Academisch Medisch Centrum
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AmsterdamNetherlandsUnknown status
Haukeland University Hospital Klinisk Forskningspost
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BergenNorwayUnknown status
General Hospital Slovenj Gradec
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Slovenj GradecSloveniaUnknown status
Emory University School of Medicine
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AtlantaUnited StatesUnknown status
Uab Medicine
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BirminghamUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Institute of Metabolic Disease
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DallasUnited StatesUnknown status
Renal Disease Research Institute, LLC - Dallas
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DallasUnited StatesUnknown status
O+O Alpan LLC
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FairfaxUnited StatesUnknown status
University of Florida
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GainesvilleUnited StatesUnknown status
Infusion Associates
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Grand RapidsUnited StatesUnknown status
University of Iowa Hospitals and Clinics
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Iowa CityUnited StatesUnknown status
University of California San Diego
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La JollaUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
University of California Irvine Center
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OrangeUnited StatesUnknown status
Phoenix Children s Hospital
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PhoenixUnited StatesUnknown status
University of Pittsburgh
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PittsburghUnited StatesUnknown status
University of Utah Hospitals & Clinics
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Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.