Extension Study of PRX-102 for up to 60 Months

Study Identifier:
PB-102-F03
ClinicalTrials.gov Identifier:
NCT01981720
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
Download document(s)

Study Details

Medical Condition
  • Fabry Disease
Study Drug
  • Biological: PRX-102 (pegunigalsidase alfa)
Date
Jan 2014 - Aug 2020
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Completion of study PB-102-F02
  • The patient signs informed consent
  • Female patients and male patients whose co-partners were of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used throughout the duration of the study and for 3 months after termination of treatment.
Exclusion Criteria
  • Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study
Healthy Volunteers
No

Protocol Summary

To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.

Study Locations

Location
Status
Location
University of Florida
Gainesville, Florida, United States, 32611
Status
N/A
Location
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Status
N/A
Location
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Status
N/A
Location
Institute of Metabolic Disease
Dallas, Texas, United States, 75226
Status
N/A
Location
O & O Alpan
Fairfax, Virginia, United States, 22030
Status
N/A
Location
Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C)
Asunción, Unmapped
Status
N/A
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