Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chiesi Farmaceutici S.p.A.
With
Chiesi USA, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
In the opinion of the Treating Physician, the patient cannot be adequately treated with any FDA approved drugs for Fabry and is not able to enroll in any current clinical trial for Fabry disease.
Patient (or legal guardian) is able to sign an informed consent prior to treatment.
A documented diagnosis of Fabry disease.
Preferably two, but at minimum 1, historical serum creatinine evaluations in the last 2 years with the latest value within the last 6 months.
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 90 days after treatment discontinuation.
You may not be if
Patients enrolled and currently treated in Study PB-102-F20, and patients enrolled and currently treated in Extension Study PB-102-F60
Patients who currently are on treatment under any other ongoing clinical trials of PRX-102
History of Type 1 (anaphylaxis or anaphylactoid like) life-threatening hypersensitivity during previous exposure to other ERTs which could not be handled with medication
Women who are breastfeeding may not participate unless they agree to stop breastfeeding.
Women who are currently pregnant.
Clareo Health | Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients
