- Trials with a EudraCT protocol (42)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (5)
42 result(s) found for: Fabry.
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: 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 (Trial now transitioned) DE (Ongoing) DK (Trial now transitioned) AT (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) NO (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned) | |||||||||||||
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 (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: 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 (Prematurely Ended) 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: 2018-001148-67 | Sponsor Protocol Number: PB-102-F60 | Start Date*: 2018-09-26 | |||||||||||
Sponsor Name:Protalix Ltd. | |||||||||||||
Full Title: Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease | |||||||||||||
Medical condition: | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) NO (Completed) CZ (Completed) ES (Ongoing) SI (Completed) NL (Completed) HU (Completed) IT (Completed) FI (Completed) FR (Completed) | |||||||||||||
Trial results: (No results available) |
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: View results |
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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