Overview

Extension Study of PRX-102 for 24 Months

Status:
Enrolling by invitation
Trial end date:
0000-00-00
Target enrollment:
18
Participant gender:
Both
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. Patients will be enrolled to receive the same dose of PRX-102 (0.2 mg/kg, 1.0 mg/kg, 2.0 mg/kg), as an intravenous infusion every 2 weeks for 24 Months.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Protalix
Last Updated:
2016-01-06
Criteria
Inclusion Criteria:

- Completion of study PB-102-F02

- The patient signs informed consent

- Female patients and male patients whose co-partners are 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 for 1 month after
treatment termination.

Exclusion Criteria:

- Pregnant or nursing

- 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