- Trials with a EudraCT protocol (41)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (3)
41 result(s) found for: Fabry'S Disease.
Displaying page 1 of 3.
EudraCT Number: 2023-000624-11 | Sponsor Protocol Number: LPS16583 | Start Date*: 2023-06-21 | |||||||||||
Sponsor Name:Genzyme Europe B.V. | |||||||||||||
Full Title: A Phase 4, open label, safety and efficacy study of Fabrazyme® (agalsidase beta) as enzyme replacement therapy in Chinese participants with Fabry Disease | |||||||||||||
Medical condition: Fabry’s disease | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
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: 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: 2018-002210-12 | Sponsor Protocol Number: ID-069A302 | Start Date*: 2019-03-18 | ||||||||||||||||
Sponsor Name:Idorsia Pharmaceuticals Ltd | ||||||||||||||||||
Full Title: A multi-center, open-label, uncontrolled, single-arm, extension study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease | ||||||||||||||||||
Medical condition: Fabry disease | ||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | |||||||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) DE (Ongoing) FR (Ongoing) AT (Ongoing) NL (Completed) BE (Ongoing) NO (Ongoing) IT (Prematurely Ended) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-002350-90 | Sponsor Protocol Number: EFC17045 | Start Date*: 2022-04-01 | |||||||||||
Sponsor Name:Sanofi-Aventis Recherche & Développement | |||||||||||||
Full Title: A randomized, double-blind, placebo-controlled, 12 month Phase 3 study to evaluate the effect of venglustat on neuropathic and abdominal pain in male and female participants ≥16 Years of Age with F... | |||||||||||||
Medical condition: | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: FI (Ongoing) DE (Ongoing) DK (Ongoing) AT (Ongoing) PL (Ongoing) GR (Ongoing) NO (Ongoing) IT (Ongoing) RO (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2004-000772-14 | Sponsor Protocol Number: TKT027 | Start Date*: 2004-07-23 | |||||||||||
Sponsor Name:TKT Inc | |||||||||||||
Full Title: A Phase I-II Pharmacokinetic/Pharmacodynamic Study of Replagal to Assess the Effects of Alternative Dose and Regimen in Patients with Fabry Disease (TKT027) | |||||||||||||
Medical condition: Fabry Disease | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: CZ (Completed) | |||||||||||||
Trial results: Removed from public view |
EudraCT Number: 2015-000697-35 | Sponsor Protocol Number: AGAL19412 | Start Date*: 2015-04-24 | |||||||||||
Sponsor Name:Genzyme, a Sanofi Company | |||||||||||||
Full Title: Evaluation of Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta (The INFORM Study) | |||||||||||||
Medical condition: Fabry Disease | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
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 (Ongoing) CZ (Ongoing) IT (Ongoing) DK (Ongoing) ES (Ongoing) GR (Ongoing) AT (Ongoing) PL (Ongoing) NL (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2016-001318-11 | Sponsor Protocol Number: PB-102-F30 | Start Date*: 2017-03-24 | |||||||||||
Sponsor Name:Protalix Ltd. | |||||||||||||
Full Title: An Open Label Study of the Safety and Efficacy of PRX 102 in Patients with Fabry Disease Currently Treated With REPLAGAL® (Agalsidase alfa) | |||||||||||||
Medical condition: Fabry disease (α-galactosidase A deficiency) | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) ES (Completed) CZ (Completed) DE (Completed) SI (Completed) NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2009-015985-75 | Sponsor Protocol Number: HGT-REP-060 | Start Date*: 2010-02-03 | |||||||||||
Sponsor Name:Shire Human Genetic Therapies (HGT), Inc. | |||||||||||||
Full Title: An Open-label Extension of Study TKT028 Evaluating Safety and Clinical Outcomes of Replagal Enzyme Replacement Therapy Administered to Adult Patients with Fabry Disease | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: PL (Completed) CZ (Completed) GB (Completed) FI (Completed) SI (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-004689-32 | Sponsor Protocol Number: SHP675-301 | Start Date*: 2021-09-24 | |||||||||||
Sponsor Name:Shire Human Genetic Therapies, Inc. | |||||||||||||
Full Title: A Phase 3, Open-label Study to Evaluate the Efficacy and Safety of REPLAGAL® in Treatment-naïve Subjects with Fabry Disease | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: PT (Ongoing) FI (Prematurely Ended) GR (Prematurely Ended) PL (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-003369-85 | Sponsor Protocol Number: ID-069A301 | Start Date*: 2018-05-14 | |||||||||||
Sponsor Name:Idorsia Pharmaceuticals Ltd | |||||||||||||
Full Title: A multicenter, double-blind, randomized, placebo-controlled, parallel-group study to determine the efficacy and safety of lucerastat oral monotherapy in adult subjects with Fabry disease. | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) AT (Completed) NL (Completed) BE (Completed) IE (Completed) ES (Ongoing) NO (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-004995-49 | Sponsor Protocol Number: LTS14116 | Start Date*: 2015-10-14 | |||||||||||
Sponsor Name:Genzyme Corporation | |||||||||||||
Full Title: An Open-label, Multicenter, Multinational Extension Study of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Adult Male Patients Diagnosed with Fabry Disease | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) PL (Completed) FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-002097-51 | Sponsor Protocol Number: FLT190-01 | Start Date*: 2020-02-12 | |||||||||||
Sponsor Name:Freeline Therapeutics Ltd | |||||||||||||
Full Title: A Phase 1/2, Baseline-controlled, Non-randomized, Open-label, Single-ascending Dose Study of a Novel Adeno-associated Viral Vector (FLT190) in Patients With Fabry disease | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Prematurely Ended) DK (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended) AT (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2012-004786-40 | Sponsor Protocol Number: PB-102-F01 | Start Date*: 2013-05-10 | |||||||||||
Sponsor Name:Protalix Ltd. | |||||||||||||
Full Title: A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks ... | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) ES (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-001966-14 | Sponsor Protocol Number: AGAL19110 | Start Date*: 2012-10-25 | |||||||||||
Sponsor Name:Genzyme, a Sanofi Company | |||||||||||||
Full Title: A Cross-sectional Study of Renal Function in Treatment-naïve, Young Male Patients with Fabry Disease | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: ES (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2007-005668-28 | Sponsor Protocol Number: AGAL06207 | Start Date*: 2008-07-29 | |||||||||||
Sponsor Name:Genzyme Europe BV | |||||||||||||
Full Title: A Randomized, Multicenter, Multinational, Phase 3B, Open-Label, Parallel-Group Study of Fabrazyme (agalsidase beta) in Treatment-Naive Male Pediatric Patients with Fabry Disease Without Severe Symp... | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) NL (Completed) PT (Prematurely Ended) DE (Prematurely Ended) CZ (Completed) FR (Completed) | |||||||||||||
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: 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 |
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