DrugBiological
Agalsidase alfa clinical trials
Also written Replagal and DRX005B.
Keep track of what changes. Save the agalsidase alfa studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Brand
- Replagal
- 14
Other names
Studies by the year they started
17 studies that test it; most in 2003 (3)
| Year | Studies |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2021 | 1 |
| 2022 | 2 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 9 · Other 8
Shire (8) · National Institute of Neurological Disorders and Stroke (NINDS) (5) · Takeda (1) · Baylor Research Institute (1) · Rigshospitalet, Denmark (1) · Assistance Publique - Hôpitaux de Paris (1)
Studies
Open first, then newest update. How each study uses agalsidase alfa is read from its arms, and is right about nine times in ten.
Testing it · 17
- A Study of Replagal in Children and Adults With Fabry Disease in IndiaRecruitingPhase 4ShireNCT05067868Written as Replagal
- A Study of REPLAGAL® in Treatment-naive Chinese Participants With Fabry DiseaseCompletedPhase 3TakedaNCT04974749Written as REPLAGAL
- A Study of Replagal in Treatment-naïve Adults With Fabry DiseaseTerminatedPhase 3ShireNCT04840667Written as REPLAGAL
- Replagal Enzyme Replacement Therapy for Children With Fabry DiseaseCompletedPhase 2ShireNCT00084084Written as Agalsidase alfa
- This Study is Designed to Evaluate PD/PK and Safety of Replagal Manufactured by Two Different Processes.CompletedPhase 2ShireNCT01304277Written as agalsidase alfa
- Safety Study of Replagal® Therapy in Children With Fabry DiseaseCompletedPhase 2ShireNCT01363492Written as Replagal (agalsidase alfa)
- Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry DiseaseCompletedPhase 3ShireNCT00864851Written as Replagal
- A Multicenter Open-Label Treatment Protocol to Observe the Safety of Replagal (Agalsidase Alfa) Enzyme Replacement Therapy in Canadian Patients With Fabry DiseaseCompletedPhase 3ShireNCT01298141Written as agalsidase alfa
- Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry DiseaseCompletedPhase 3ShireNCT01124643Written as Replagal
- Dosing Study of Replagal in Patients With Fabry DiseaseCompletedPhase 2Baylor Research InstituteNCT00068107Written as Replagal
- Ophthalmic Findings During 10-year Enzyme Substitution of Danish Fabry Patients.CompletedPhase 4Rigshospitalet, DenmarkNCT01997489Written as Enzyme replacement
- An Open-Label Maintenance Study of the Enzyme Replacement Therapy Replagal in Patients With Fabry DiseaseCompletedPhase 1National Institute of Neurological Disorders and Stroke (NINDS)NCT00357786Written as Replagal
- Alternative Dosing and Regimen of Replagal to Treat Fabry DiseaseCompletedPhase 2National Institute of Neurological Disorders and Stroke (NINDS)NCT00075244Written as Replagal
- Replagal Enzyme Replacement Therapy for Adults With Fabry DiseaseCompletedPhase 4National Institute of Neurological Disorders and Stroke (NINDS)NCT00097890Written as Replagal (Agalsidase Alfa)
- Alpha-Galactosidase A Replacement Therapy for Fabry DiseaseCompletedPhase 2National Institute of Neurological Disorders and Stroke (NINDS)NCT00048906Written as DRX005B
- An Open-Label Clinical Trial of Replagal Enzyme Therapy in Children Ages 7-17 Years With Fabry DiseaseCompletedPhase 2National Institute of Neurological Disorders and Stroke (NINDS)NCT00071877Written as Replagal
- Evaluation of Efficacy and Safety of Agalsidase Beta in Heterozygous Females for Fabry DiseaseStatus unknownPhase 4Assistance Publique - Hôpitaux de ParisNCT00487630Written as recombinant alpha-galactosidase A
Given in every arm · 1 — agalsidase alfa is usual care beside what is tested
As the comparator · 2 — what is tested is compared with agalsidase alfa
- A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry DiseaseActive, not recruitingPhase 3SanofiNCT05280548Written as Agalsidase alfa
- 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 DiseaseWithdrawnPhase 4SanofiNCT04143958Written as agalsidase alfa
Codes
What other systems call agalsidase alfa · ClinicalTrials.gg INT000931
- MeSH (NLM) C000627036agalsidase alfaConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) 2HLC17MX9GAGALSIDASE ALFAConfirmed FDA, NLM
- RxNorm 259351One source FDA
- NCI Thesaurus C74209Agalsidase AlfaOne source FDA
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000627036 | agalsidase alfa | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | 2HLC17MX9G | AGALSIDASE ALFA | Confirmed FDA, NLM |
| RxNorm | 259351 | — | One source FDA |
| NCI Thesaurus | C74209 | Agalsidase Alfa | One source FDA |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.