Extension Study of PRX-102 for up to 60 Months

Completed · Phase 1/Phase 2

Conditions studied: Fabry Disease

In brief

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.

Key facts

Study ID: NCT01981720
Run by: Protalix
People needed: 15
Starts: 2014-01-16
Expected to finish: 2021-11-09
Last updated by the study team: 2023-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University of Florida — Gainesville, Florida, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
Institute of Metabolic Disease — Dallas, Texas, United States
O & O Alpan — Fairfax, Virginia, United States
Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C) — Asunción, Paraguay
Hospital de Dia Quiron Zaragoza — Zaragoza, Spain
The Royal Free Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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