Phase 2
Completed N=15
Extension Study of PRX-102 for up to 60 Months
Source: ClinicalTrials.gov NCT01981720 ↗Enrolled (actual)
15
Serious AEs
20.0%
Results posted
Feb 2023
Primary outcomePrimary: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 — 13; 13; 5; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03 |
13; 13; 5; 2; 4; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01981720). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.