Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease

Study Identifier:
CLI-06657AA1-04
ClinicalTrials.gov Identifier:
NCT03566017
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Protocol
Available Languages: English
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Statistical Analysis Plan
Available Languages: English
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Plain Language Summary
Available Languages: English
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Study Details

Medical Condition
  • Fabry Disease
Study Drug
  • Drug: pegunigalsidase alfa
Date
Sep 2018 - Jan 2025
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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.
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-06657AA1-04 (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.

Study Locations

Location
Status
Location
UAB Medicine
Birmingham, Alabama, United States, 35233
Status
N/A
Location
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Status
N/A
Location
University of California San Diego
La Jolla, California, United States, 92037
Status
N/A
Location
University of California Irvine Center
Orange, California, United States, 92868
Status
N/A
Location
University of Florida
Gainesville, Florida, United States, 32610
Status
N/A
Location
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Status
N/A
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