Extension Study of PRX-102 for up to 60 Months
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hematology, Metabolic |
| Therapuetic Areas: | Hematology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | December 2013 |
| End Date: | March 2021 |
A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients
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 PRX-102 at the dose of, 1.0 mg/kg, as an
intravenous infusion every 2 weeks (+/- 3 days). The duration of treatment will be up to 60
months or until PRX-102 is commercially available to the subject at the discretion of the
Sponsor and no less than 36 months.
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 PRX-102 at the dose of, 1.0 mg/kg, as an
intravenous infusion every 2 weeks (+/- 3 days). The duration of treatment will be up to 60
months or until PRX-102 is commercially available to the subject at the discretion of the
Sponsor and no less than 36 months.
Inclusion Criteria:
- Completion of study PB-102-F02
- The patient signs informed consent
- Female patients 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:
- 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
We found this trial at
5
sites
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1450 Mariano Roque Alonso
Asunción,
Asunción,
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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