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