Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

Study Identifier:
CLI-06657AA1-03
ClinicalTrials.gov Identifier:
NCT03614234
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Active, not recruiting

Study Details

Medical Condition
  • Fabry Disease
Study Drug
  • Drug: pegunigalsidase alfa
Date
Nov 2018 - Apr 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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.
Exclusion Criteria
  • 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.
Healthy Volunteers
No

Protocol Summary

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.

Study Locations

Location
Status
Location
UAB Medicine
Birmingham, Alabama, United States, 35233
Status
N/A
Location
Emory University School of Medicine
Atlanta, Georgia, United States, 30307
Status
N/A
Location
University of Iowa Hospitals and Clinica
Iowa City, Iowa, United States, 52242
Status
N/A
Location
Infusion Associates
Grand Rapids, Michigan, United States, 49525
Status
N/A
Location
Renal Disease Research Institute, LLC
Dallas, Texas, United States, 75235
Status
N/A
Location
University of Utah Hospitals & Clinics
Salt Lake City, Utah, United States, 84112
Status
N/A
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