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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.
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Of Antwerp
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EdegemBelgiumCompleted
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaCompleted
Rigshospitalet
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Copenhagen OeDenmarkCompleted
Addenbrooke's Hospital
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CambridgeUnited KingdomUnknown status
The Royal Free Hospital
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LondonUnited KingdomUnknown status
Azienda Ospedaliera Universitaria Federico II Di Napoli
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NaplesItalyCompleted
Helse Bergen HF
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BergenNorwayCompleted
Emory University School of Medicine
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AtlantaUnited StatesUnknown status
Uab Medicine
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BirminghamUnited StatesUnknown status
Renal Disease Research Institute, LLC
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DallasUnited StatesUnknown status
O & O Alpan
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FairfaxUnited StatesUnknown status
Infusion Associates
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Grand RapidsUnited StatesUnknown status
University of Iowa Hospitals and Clinica
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Iowa CityUnited StatesUnknown status
University of Utah Hospitals & Clinics
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Salt Lake CityUnited StatesUnknown status

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