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Completed Phase 3 Interventional

Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

ClinicalTrials.gov ID: NCT03614234

Public ClinicalTrials.gov record NCT03614234. 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.

ClinicalTrials.gov public records Last synced Jun 26, 2026, 10:46 AM EDT

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 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease

Study identification

NCT ID
NCT03614234
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Chiesi Farmaceutici S.p.A.
Industry
Enrollment
29 participants

Conditions and interventions

Conditions

Interventions

  • pegunigalsidase alfa Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
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
Nov 12, 2018
Primary completion
Apr 12, 2026
Completion
Apr 12, 2026
Last update posted
May 21, 2026

2018 – 2026

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
UAB Medicine Birmingham Alabama 35233
Emory University School of Medicine Atlanta Georgia 30307
University of Iowa Hospitals and Clinica Iowa City Iowa 52242
Infusion Associates Grand Rapids Michigan 49525
Renal Disease Research Institute, LLC Dallas Texas 75235
University of Utah Hospitals & Clinics Salt Lake City Utah 84112
O & O Alpan Fairfax Virginia 22030

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 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03614234, 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 May 21, 2026 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03614234 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →