Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
Public ClinicalTrials.gov record NCT03566017. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who had successfully completed studies PB-102-F20, PB-102-F30, or at least 48 months in study PB-102-F03.
Study identification
- NCT ID
- NCT03566017
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 97 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 16, 2018 (Actual)
- Primary completion
- Jan 21, 2025 (Actual)
- Completion
- Jan 21, 2025 (Actual)
- Last update posted
- Mar 24, 2026
2018 – 2025
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Medicine | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| University of California San Diego | La Jolla | California | 92037 | — |
| University of California Irvine Center | Orange | California | 92868 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Infusion Associates | Grand Rapids | Michigan | 49525 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Renal Disease Research Institute, LLC - Dallas | Dallas | Texas | 75235 | — |
| Institute of Metabolic Disease | Dallas | Texas | 75246 | — |
| University of Utah Hospitals & Clinics | Salt Lake City | Utah | 84108 | — |
| O+O Alpan LLC | Fairfax | Virginia | 22030 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03566017, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03566017 live on ClinicalTrials.gov.