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Treatment Protocol of Replagal for Patients With Fabry Disease

ClinicalTrials.gov ID: NCT01031173

Public ClinicalTrials.gov record NCT01031173. 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 Oct 22, 2026, 5:25 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

An Open-label Treatment Protocol to Evaluate the Safety of Replagal Treatment in Patients With Fabry Disease.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study will evaluate the safety and efficacy of Replagal® (agalsidase alfa) at a dose of 0.2 mg/kg infused intravenously (IV) over 40 minutes, every other week. The study will monitor the course of disease in males and females with Fabry disease who are naive to treatment or were previously treated with agalsidase beta (Fabrazyme®).

Study identification

NCT ID
NCT01031173
Recruitment status
No Longer Available
Study type
Expanded access
Phase
Not listed
Lead sponsor
Shire
Industry
Enrollment
Not listed

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
May 24, 2021

United States locations

U.S. sites
25
U.S. states
16
U.S. cities
24
Facility City State ZIP Site status
AKDHC Tucson Campbell Tucson Arizona 85718 —
University of California San Diego Medical Center La Jolla California 92093-0830 —
Kaiser Medical Group Southern CA, Regional Metabolic Services Los Angeles California 90027 —
Children's Hospital & Research Center Oakland Oakland California 94609 —
UC Davis Children's Hospital Sacramento California 95817 —
Central Coast Nephrology Salinas California 93901 —
Denver Nephrologists, PC Denver Colorado 80230 —
University Research Foundation for Lysosomal Storage Disorders Coral Springs Florida 33065 —
Stuart Oncology Associates Stuart Florida 34994 —
Emory University School of Medicine Decatur Georgia 30033 —
Emory University Decatur Georgia 30033 —
University of Iowa Health Center Iowa City Iowa 52242 —
Baystate Medical Center Springfield Massachusetts 01199 —
Infusion Associates Grand Rapids Michigan 49525 —
University of Missouri Healthcare Columbia Missouri 65212 —
St. Joseph's Regional Medical Center Paterson New Jersey 07503 —
North Shore Hematology/Oncology Manhasset New York 11030 —
New York University School of Medicine New York New York 10016 —
Fullerton Genetics Center-Mission, St. Joseph's Hospital Asheville North Carolina 28803 —
The Toledo Hospital Toledo Ohio 43606 —
Oregon Health and Science University Portland Oregon 97239 —
Baylor University Medical Center Dallas Texas 75246 —
Tidewater Kidney Specialists Chesapeake Virginia 23320 —
Carilion New River Valley Medical Center Christiansburg Virginia 24073 —
O & O Alpan LLC Springfield Virginia 22152 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01031173, 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 24, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01031173 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →