Agalsidase alfa
- Generic Name
- Agalsidase alfa
- Brand Names
- Replagal
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- -
- Unique Ingredient Identifier
- 2HLC17MX9G
- Background
Agalsidase alfa is a recombinant human α-galactosidase A similar to agalsidase beta. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta. Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009.
Agalsidase alfa was granted EMA approval on 3 August 2001.
- Indication
Agalsidase alfa is indicated in the treatment of Fabry disease.
- Associated Conditions
- Fabry's Disease
- Associated Therapies
- Enzyme replacement
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease
- Conditions
- Interventions
- First Posted Date
- 2022-03-15
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 104
- Registration Number
- NCT05280548
- Locations
- 🇺🇸
University of Alabama -The Kirklin Clinic- Site Number : 8400010, Birmingham, Alabama, United States
🇺🇸University of California Los Angeles Medical Center- Site Number : 8400008, Los Angeles, California, United States
🇺🇸Emory University School of Medicine - Atlanta- Site Number : 8400009, Atlanta, Georgia, United States
To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease
- Conditions
- Interventions
- First Posted Date
- 2019-10-30
- Last Posted Date
- 2023-04-07
- Lead Sponsor
- Sanofi
- Registration Number
- NCT04143958
Evaluation of Efficacy and Safety of Agalsidase Beta in Heterozygous Females for Fabry Disease
- Conditions
- First Posted Date
- 2007-06-18
- Last Posted Date
- 2007-06-18
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Target Recruit Count
- 34
- Registration Number
- NCT00487630
- Locations
- 🇫🇷
Centre de reference de la maladie de Fabry et des maladies hereditaires du tissu conjonctif. Assistance Publique - Hôpitaux de Paris, Paris, France
Replagal Enzyme Replacement Therapy for Children With Fabry Disease
- First Posted Date
- 2004-06-07
- Last Posted Date
- 2021-07-30
- Lead Sponsor
- Shire
- Target Recruit Count
- 17
- Registration Number
- NCT00084084
- Locations
- 🇺🇸
Tucson Access Center of Arizona Kidney Disease Hypertension Center, Tucson, Arizona, United States
🇺🇸Clinical Center, National Institutes of Health, Bethesda, Maryland, United States
🇺🇸Children's Physician Group, Palm Beach Gardens, Florida, United States
Drug Development Updates
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