Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease
Completed · Phase 3
Conditions studied: Fabry Disease
In brief
The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.
Key facts
- Study ID
- NCT00864851
- Run by
- Shire
- People needed
- 44
- Starts
- 2008-12-29
- Expected to finish
- 2012-07-05
- Last updated by the study team
- 2021-06-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- >18 years-old;
- Male:Fabry disease confirmed by deficiency of alfa galactosidase A activity OR Female:Fabry disease confirmed by a mutation of the alfa galactosidase A gene;
- ERT-naïve;
- LVM/h > 50g/m2.7 for males and >47 g/m2.7 for females;
- Negative pregnancy test at enrollment and contraception use required throughout study for female patients;
- Signed informed consent;
You may not qualify if…
- Class IV heart failure;
- Clinically significant hypertension;
- Hemodynamically significant valvular stenosis or regurgitation;
- Morbid obesity;
- Known autosomal dominant sarcoplasmic contractile protein gene mutation;
- Treatment with any investigational drug or device within the 30 days;
- Unable to comply with the protocol as determined by the Investigator;
- Positive for hepatitis B, hepatitis C or HIV
Where it is running
- AKDHC Tucson Access Center — Tucson, Arizona, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- New York Unversity School of Medicine — New York, New York, United States
- O & O Alpan, LLC — Springfield, Virginia, United States
- The Royal Melbourne Hospital — Parkville, Victoria, Australia
- The Charles University Hospital — Prague, Czechia
- Turku University Central Hospital — Turku, Finland
- Gobemador Irala y Coronel Lopez - Barrio Sojania — Asunción, Paraguay
- Szpital Uniwersytecki w Krakowie — Krakow, Poland
- Instytut Kardiologii — Warsaw, Poland
- General Hospital Slovenj Gradec — Slovenj Gradec, Slovenia
- Salford Royal NHS Foundation Trust — Salford, United Kingdom
Full record on ClinicalTrials.gov
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