- Trials with a EudraCT protocol (14)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
14 result(s) found for: Fabry and migalastat.
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EudraCT Number: 2017-000146-21 | Sponsor Protocol Number: AT1001-020 | Start Date*: 2019-08-29 | |||||||||||
Sponsor Name:Amicus Therapeutics, UK Ltd | |||||||||||||
Full Title: AN OPEN-LABEL STUDY OF THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF 12-MONTH TREATMENT WITH MIGALASTAT IN PEDIATRIC SUBJECTS (AGED 12 TO <18 YEARS) WITH FABRY DISEASE AND AMENABL... | |||||||||||||
Medical condition: Fabry disease and with amenable GLA variants | |||||||||||||
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Population Age: Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) DE (Ongoing) ES (Completed) IT (Ongoing) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-000222-21 | Sponsor Protocol Number: AT1001-036 | Start Date*: 2020-08-25 | |||||||||||
Sponsor Name:Amicus Therapeutics, UK Limited | |||||||||||||
Full Title: A LONG-TERM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACODYNAMICS, AND EFFICACY OF MIGALASTAT IN SUBJECTS > 12 YEARS OF AGE WITH FABRY DISEASE AND AMENABLE GLA VARIANTS | |||||||||||||
Medical condition: Fabry disease and with amenable GLA variants | |||||||||||||
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Population Age: Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2011-004800-40 | Sponsor Protocol Number: AT1001-041 | Start Date*: 2012-01-25 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: An Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in Subjects with Fabry Disease. | |||||||||||||
Medical condition: Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme α-galactosidase A. | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) ES (Completed) IT (Completed) DK (Completed) BE (Completed) AT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2007-001838-13 | Sponsor Protocol Number: FAB-CL-205 | Start Date*: 2009-05-05 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: Open Label Extension Study to Evaluate the Long-term Safety Tolerability and Pharmacodynamics of AT1001 in Patients with Fabry Disease | |||||||||||||
Medical condition: Fabry Disease | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-002320-20 | Sponsor Protocol Number: EFC16158 | Start Date*: 2022-04-11 | |||||||||||
Sponsor Name:sanofi-aventis recherche et développement | |||||||||||||
Full Title: A randomized, open-label, parallel-group, 18-month Phase 3 study to evaluate the effect of venglustat compared with usual standard of care on left ventricular mass index in participants with Fabry ... | |||||||||||||
Medical condition: Fabry’s disease | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: NO (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) DK (Trial now transitioned) ES (Ongoing) GR (Trial now transitioned) AT (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2005-004384-33 | Sponsor Protocol Number: AA1565522 (FAB-CL-203) | Start Date*: 2005-12-19 | |||||||||||
Sponsor Name:Amicus Therapeutics | |||||||||||||
Full Title: A Phase 2, Open-Label, Single Dose Level, 24-Week Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AT1001 in Patients with Fabry Disease | |||||||||||||
Medical condition: Fabry Disease | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2006-000181-36 | Sponsor Protocol Number: FAB-CL-204 | Start Date*: 2006-03-17 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: A Phase 2, Open-Label, Multiple Dose Level, 12-Week Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AT1001 in Female Patients with Fabry Disease | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults | Gender: Female | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-001133-40 | Sponsor Protocol Number: AT1001-025 | Start Date*: 2020-01-06 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Fabry Subjects with Amenable GLA Variants and Severe Renal Impairment | |||||||||||||
Medical condition: Fabry Subjects with Amenable GLA Variants and Severe Renal Impairment | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2014-002701-38 | Sponsor Protocol Number: AT1001-042 | Start Date*: 2014-12-17 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: An Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of Migalastat Hydrochloride Monotherapy in subjects with Fabry Disease | |||||||||||||
Medical condition: Fabry disease is a rare X-linked lysosomal storage disorder caused by mutations in the gene (GLA) that encodes the lysosomal enzyme a-galactosidase A. | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: AT (Completed) BE (Completed) GB (Completed) ES (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-022709-16 | Sponsor Protocol Number: AT1001-013 | Start Date*: 2011-09-12 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: AN OPEN-LABEL PHASE 2A STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT1001 (MIGALASTAT HYDROCHLORIDE) AND AGALSIDASE IN SUBJECTS WITH FABRY DISEASE | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: BE (Completed) GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-000065-20 | Sponsor Protocol Number: LPS15919 | Start Date*: 2020-02-05 | |||||||||||
Sponsor Name:Sanofi Aventis Groupe (SAG) | |||||||||||||
Full Title: A randomized, open-label, active comparator, 2-arm, prospective study to assess the glycosphingolipid clearance and clinical effects of switching to agalsidase beta (Fabrazyme®) versus continuing o... | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: NO (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2009-013459-31 | Sponsor Protocol Number: AT1001-011 | Start Date*: 2009-12-10 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACODYNAMICS OF AT1001 IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS | |||||||||||||
Medical condition: Fabry Disease | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) FR (Completed) DE (Completed) NL (Completed) BE (Completed) ES (Completed) IT (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-022636-37 | Sponsor Protocol Number: AT1001-012 | Start Date*: 2011-01-18 | |||||||||||
Sponsor Name:Amicus Therapeutics, Inc. | |||||||||||||
Full Title: A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOU... | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: BE (Completed) GB (Completed) DK (Completed) AT (Completed) GR (Completed) DE (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-000667-24 | Sponsor Protocol Number: ST-920-201 | Start Date*: 2019-11-12 | |||||||||||
Sponsor Name:Sangamo Therapeutics, Inc. | |||||||||||||
Full Title: A Phase I/II, Multicenter, Open-Label, SingleDose, Dose-Ranging Study to Assess the Safety and Tolerability of ST-920, a rAAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects with Fabry Dise... | |||||||||||||
Medical condition: Fabry Disease (X-linked lysosomal storage disease) | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
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