Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
NCT ID: NCT03566017
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
97 participants
INTERVENTIONAL
2018-09-16
2025-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental open label
pegunigalsidase alfa
pegunigalsidase alfa
Recombinant human alpha galactosidase A
Interventions
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pegunigalsidase alfa
Recombinant human alpha galactosidase A
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The patient signs informed consent
3. Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception. 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.
Exclusion Criteria
18 Years
60 Years
ALL
No
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Locations
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UAB Medicine
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
University of California San Diego
La Jolla, California, United States
University of California Irvine Center
Orange, California, United States
University of Florida
Gainesville, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Infusion Associates
Grand Rapids, Michigan, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Renal Disease Research Institute, LLC - Dallas
Dallas, Texas, United States
Institute of Metabolic Disease
Dallas, Texas, United States
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States
O+O Alpan LLC
Fairfax, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Melbourne Hospital
Parkville, Victoria, Australia
Capital District Health Authority
Halifax, Nova Scotia, Canada
Vseobecna fakultni nemocnice v Praze
Prague, Czech Republic, Czechia
Turku University Central Hospital
Turku, , Finland
Hospital Raymond-Poincaré
Garches, , France
Semmelweis Egyetem
Budapest, , Hungary
Azienda Ospedaliera Universitaria "Federico II"
Napoli, Via Pansini, Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
Haukeland University Hospital Klinisk Forskningspost
Bergen, , Norway
General Hospital Slovenj Gradec
Slovenj Gradec, , Slovenia
Hospital de Dia Quiron Zaragoza
Zaragoza, , Spain
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Edgbaston, Birmingham, United Kingdom
Salford Royal
Salford, Greater Manchester, United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
The Royal Free Hospital
London, , United Kingdom
Countries
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Other Identifiers
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CLI-06657AA1-04
Identifier Type: -
Identifier Source: org_study_id
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