Treatment Protocol of Replagal for Patients With Fabry Disease

NO_LONGER_AVAILABLE

Conditions studied: Fabry Disease

In brief

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®).

Key facts

Study ID

NCT01031173

Run by

Shire

Last updated by the study team

2021-05-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Fabry disease.
• Patient is willing and able to provide written informed consent, and assent if applicable.
• Females of childbearing potential must agree to use a method of birth control throughout the study and for at least 30 days after the final infusion. The method of contraception must be considered adequate and appropriate in the opinion of the investigator.

You may not qualify if…

• Hypersensitivity to Replagal, the active substance, or any of the excipients.
• The patient is pregnant or breast feeding.
• Concomitant use of agalsidase beta (Fabrazyme).
• Has received treatment with any investigation drug or device within the 30 days prior to study entry.
• Otherwise unsuitable for the study, in the opinion of the Investigator.

Where it is running

• AKDHC Tucson Campbell — Tucson, Arizona, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• Kaiser Medical Group Southern CA, Regional Metabolic Services — Los Angeles, California, United States
• Children's Hospital & Research Center Oakland — Oakland, California, United States
• UC Davis Children's Hospital — Sacramento, California, United States
• Central Coast Nephrology — Salinas, California, United States
• Denver Nephrologists, PC — Denver, Colorado, United States
• University Research Foundation for Lysosomal Storage Disorders — Coral Springs, Florida, United States
• Stuart Oncology Associates — Stuart, Florida, United States
• Emory University School of Medicine — Decatur, Georgia, United States
• Emory University — Decatur, Georgia, United States
• University of Iowa Health Center — Iowa City, Iowa, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Infusion Associates — Grand Rapids, Michigan, United States
• University of Missouri Healthcare — Columbia, Missouri, United States
• St. Joseph's Regional Medical Center — Paterson, New Jersey, United States
• North Shore Hematology/Oncology — Manhasset, New York, United States
• New York University School of Medicine — New York, New York, United States
• Fullerton Genetics Center-Mission, St. Joseph's Hospital — Asheville, North Carolina, United States
• The Toledo Hospital — Toledo, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Tidewater Kidney Specialists — Chesapeake, Virginia, United States
• Carilion New River Valley Medical Center — Christiansburg, Virginia, United States
• O & O Alpan LLC — Springfield, Virginia, United States

Full record on ClinicalTrials.gov

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