- Trials with a EudraCT protocol (13)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
13 result(s) found for: Agalsidase Beta.
Displaying page 1 of 1.
EudraCT Number: 2019-000064-21 | Sponsor Protocol Number: LPS15918 | Start Date*: Information not available in EudraCT | |||||||||||
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 benefits of agalsidase beta (Fabrazyme®) in male patients with classic F... | |||||||||||||
Medical condition: Fabry's disease | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: NO (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended) | |||||||||||||
Trial results: View results |
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: 2016-000378-38 | Sponsor Protocol Number: PB-102-F20 | Start Date*: 2016-09-07 | |||||||||||
Sponsor Name:Protalix Ltd. | |||||||||||||
Full Title: A Randomized, Double blind, Active Control Study of the Safety and Efficacy of PRX-102 compared to Agalsidase Beta on Renal Function in Patients with Fabry Disease Previously Treated With Agalsidas... | |||||||||||||
Medical condition: Fabry disease (α-galactosidase A deficiency) | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) HU (Completed) ES (Completed) CZ (Completed) NO (Completed) BE (Completed) NL (Completed) SI (Completed) IT (Completed) FI (Completed) FR (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: 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: 2017-001528-23 | Sponsor Protocol Number: PB-102-F50 | Start Date*: 2017-10-18 | |||||||||||
Sponsor Name:Protalix Ltd. | |||||||||||||
Full Title: A Phase 3, Open Label, Switch Over Study to Assess the Safety, Efficacy and Pharmacokinetics of pegunigalsidase alfa (PRX-102) 2 mg/kg Administered by Intravenous Infusion Every 4 Weeks for 52 week... | |||||||||||||
Medical condition: Fabry disease (α-galactosidase A deficiency) | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) BE (Completed) ES (Completed) CZ (Completed) DK (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-000368-27 | Sponsor Protocol Number: MAN-ALG-18-001 | Start Date*: 2018-10-22 | |||||||||||
Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE | |||||||||||||
Full Title: ND | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2006-001910-33 | Sponsor Protocol Number: AGAL02603 | Start Date*: 2007-12-05 | |||||||||||
Sponsor Name:Genzyme Europe BV | |||||||||||||
Full Title: A Multicenter, Multinational Study of the Effects of Fabrazyme® (agalsidase beta) Treatment on Lactation and Infants | |||||||||||||
Medical condition: Fabry disease | |||||||||||||
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Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) AT (Ongoing) | |||||||||||||
Trial results: View results |
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: 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: 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: 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: 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 |
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