- Trials with a EudraCT protocol (70)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
70 result(s) found for: hemophilia.
Displaying page 1 of 4.
EudraCT Number: 2021-004039-10 | Sponsor Protocol Number: NL78130.041.21 | Start Date*: 2022-06-24 | |||||||||||
Sponsor Name:UMC Utrecht - Van Creveldkliniek | |||||||||||||
Full Title: Pharmacokinetic-guided dosing of emicizumab in congenital haemophilia A patients – The DosEmi study | |||||||||||||
Medical condition: Congenital hemophilia A | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: NL (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2009-016029-32 | Sponsor Protocol Number: ITI-CE-PR | Start Date*: 2010-02-25 | |||||||||||
Sponsor Name:STRUTTURA SEMPLICE GESTIONE-ORG.-FUNZ. HUB EMOFILIA | |||||||||||||
Full Title: MECHANISM OF ACTION AND EFFICACY OF AN ALTERNATIVE IMMUNOTOLERANCE REGIMEN BASED ON MODULATION OF IMMUNE RESPONSES: A NEW CHANCE FOR HAEMOPHILIA PATIENTS WITH REFRACTORY INHIBITORS ? | |||||||||||||
Medical condition: Haemophilic patients, with high responding inhibitor (>5 BU/ml), in whom previous ITI failed and who undergo the second line ITI protocol | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2013-002686-19 | Sponsor Protocol Number: HIPS-2013 | Start Date*: 2013-08-23 | |||||||||||
Sponsor Name:Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano | |||||||||||||
Full Title: Hemophilia Inhibitor PUP Study - HIPS | |||||||||||||
Medical condition: Infants or children with severe haemophilia A previously untreated with factor concentrates. | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: IT (Ongoing) SE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-004858-30 | Sponsor Protocol Number: BAY94-9027/21824 | Start Date*: 2022-09-05 | ||||||||||||||||
Sponsor Name:Bayer Consumer Care AG | ||||||||||||||||||
Full Title: A phase 3, single group treatment, open-label, study to evaluate the safety of BAY 94-9027 infusions for prophylaxis and treatment of bleeding in previously treated children aged 7 to <12 years wit... | ||||||||||||||||||
Medical condition: Severe hemophilia A (<1% FVIII:C) | ||||||||||||||||||
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Population Age: Children, Under 18 | Gender: Male | |||||||||||||||||
Trial protocol: NO (Ongoing) IT (Ongoing) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-003213-34 | Sponsor Protocol Number: 270-205 | Start Date*: 2020-09-25 | |||||||||||
Sponsor Name:BioMarin Pharmaceutical Inc. | |||||||||||||
Full Title: A Phase 1/2 Safety, Tolerability, and Efficacy Study of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Active or Prior Inhibitors | |||||||||||||
Medical condition: Hemophilia A | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) IT (Ongoing) DE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2012-001039-30 | Sponsor Protocol Number: BetHäm2012 | Start Date*: 2013-03-06 | |||||||||||
Sponsor Name:Hospital of Goethe-Universitiy | |||||||||||||
Full Title: BetHäm2012: A monocenter, single-blind, randomized, 2-armed, placebo-controlled, cross-over study to investigate coagulation markers in patients with haemophilia A after administration of Betain | |||||||||||||
Medical condition: In this study patients with haemophilia A are included. | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-003427-38 | Sponsor Protocol Number: MOTIVATE | Start Date*: 2020-03-12 | |||||||||||
Sponsor Name:HZRM – Hämophilie-Zentrum Rhein Main GmbH | |||||||||||||
Full Title: MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial | |||||||||||||
Medical condition: Inhibitor-Positive patients with Haemophilia A | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Ongoing) NO (Ongoing) SE (Ongoing) FI (Ongoing) HR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2017-001271-23 | Sponsor Protocol Number: C0371004 | Start Date*: 2019-02-20 | ||||||||||||||||
Sponsor Name:Pfizer Inc. | ||||||||||||||||||
Full Title: AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE PROSPECTIVE EFFICACY AND SELECTED SAFETY DATA OF CURRENT FACTOR IX (FIX) OR FACTOR VIII (FVIII) PROPHYLAXIS REPLA... | ||||||||||||||||||
Medical condition: Moderately Severe To Severe Adult Hemophilia B Participants (FIX:C≤2%) Who Are Negative For Neutralizing Antibodies (NAb) To Adeno-Associated Virus Vector (AAV) Spark100. Moderately severe to sever... | ||||||||||||||||||
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Population Age: Adults | Gender: Male | |||||||||||||||||
Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) IE (Completed) DE (Ongoing) FR (Ongoing) ES (Ongoing) NL (Ongoing) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2017-000806-39 | Sponsor Protocol Number: BAY2599023/19429 | Start Date*: 2019-02-25 | |||||||||||
Sponsor Name:Bayer AG | |||||||||||||
Full Title: A phase 1/2 open-label safety and dose-finding study of BAY 2599023 (DTX201), an adeno-associated virus (AAV) hu37-mediated gene transfer of B-domain deleted human factor VIII, in adults with sever... | |||||||||||||
Medical condition: Hemophilia A | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Trial now transitioned) BG (Trial now transitioned) NL (Trial now transitioned) FR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2017-003215-19 | Sponsor Protocol Number: 270-301 | Start Date*: 2017-11-25 |
Sponsor Name:BioMarin Pharmaceutical Inc. | ||
Full Title: A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Res... | ||
Medical condition: Haemophilia A | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male | |
Trial protocol: GB (GB - no longer in EU/EEA) DE (Ongoing) ES (Ongoing) FR (Ongoing) BE (Ongoing) IT (Ongoing) | ||
Trial results: (No results available) |
EudraCT Number: 2020-003467-26 | Sponsor Protocol Number: NN7769-4516 | Start Date*: 2021-11-30 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors | ||||||||||||||||||
Medical condition: Haemophilia A Haemophilia A with inhibitors | ||||||||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: NL (Ongoing) PL (Ongoing) IT (Ongoing) ES (Ongoing) PT (Ongoing) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2009-011186-88 | Sponsor Protocol Number: ABB-09-001 | Start Date*: 2009-09-08 | |||||||||||
Sponsor Name:FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI | |||||||||||||
Full Title: Desarrollo de inhibidores en pacientes no tratados previamente (PUP) o en pacientes mínimamente tratados con componentes sanguíneos (MBCTP) al ser expuestos a concentrados de derivados plasmáticos ... | |||||||||||||
Medical condition: El estudio es un ensayo clínico abierto, aleatorizado, controlado, prospectivo, multicéntrico, internacional e independiente sobre la frecuencia de formación de inhibidores en pacientes no tratados... | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: ES (Prematurely Ended) IT (Completed) PT (Completed) FR (Ongoing) DE (Restarted) AT (Prematurely Ended) BE (Ongoing) GB (GB - no longer in EU/EEA) SK (Ongoing) CZ (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2015-001395-21 | Sponsor Protocol Number: ALN-AT3SC-002 | Start Date*: 2015-07-22 | ||||||||||||||||
Sponsor Name:Genzyme Corporation | ||||||||||||||||||
Full Title: An Open-label Extension Study of Subcutaneously Administered Fitusiran in Patients with Moderate or Severe Hemophilia A or B who have Participated in a Previous Clinical Study with Fitusiran | ||||||||||||||||||
Medical condition: Hemophilia A or Hemophilia B | ||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) BG (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2018-003660-31 | Sponsor Protocol Number: B7841005 | Start Date*: 2020-09-07 | |||||||||||||||||||||
Sponsor Name:Pfizer Inc. | |||||||||||||||||||||||
Full Title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis | |||||||||||||||||||||||
Medical condition: Hemophilia A or B | |||||||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||||||||||||
Trial protocol: DE (Prematurely Ended) FR (Ongoing) BG (Completed) GB (GB - no longer in EU/EEA) ES (Restarted) IE (Completed) HR (Completed) IT (Ongoing) | |||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2016-001463-36 | Sponsor Protocol Number: EFC14768 | Start Date*: 2018-07-25 | ||||||||||||||||
Sponsor Name:Genzyme Corporation | ||||||||||||||||||
Full Title: ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients with Hemophilia A or B, with Inhibitory Antibodies to Factor VIII or IX | ||||||||||||||||||
Medical condition: Hemophilia A or Hemophilia B | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) DE (Completed) DK (Completed) NL (Not Authorised) IT (Prematurely Ended) Outside EU/EEA | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2019-004451-37 | Sponsor Protocol Number: C3731003 | Start Date*: 2021-09-24 | |||||||||||
Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | |||||||||||||
Full Title: Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Sev... | |||||||||||||
Medical condition: hemophilia A | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: DE (Temporarily Halted) IT (Ongoing) ES (Restarted) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-002880-25 | Sponsor Protocol Number: LTE15174 | Start Date*: 2019-03-08 | ||||||||||||||||
Sponsor Name:Genzyme Corporation | ||||||||||||||||||
Full Title: ATLAS-OLE: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients with Hemophilia A or B, with or without Inhibitory Antibodies to Factor VIII or IX | ||||||||||||||||||
Medical condition: Hemophilia A or Hemophilia B | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: IE (Restarted) GB (GB - no longer in EU/EEA) DE (Completed) PT (Completed) HU (Ongoing) ES (Prematurely Ended) FR (Ongoing) DK (Temporarily Halted) Outside EU/EEA IT (Ongoing) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-000679-18 | Sponsor Protocol Number: EFC15467 | Start Date*: 2019-07-23 | |||||||||||
Sponsor Name:Genzyme Corporation | |||||||||||||
Full Title: ATLAS-PEDS: An open-label, multinational study of fitusiran prophylaxis in male pediatric subjects aged 1 to less than 12 years with hemophilia A or B | |||||||||||||
Medical condition: Hemophilia A or B | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: ES (Restarted) Outside EU/EEA IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-003086-33 | Sponsor Protocol Number: C0371002 | Start Date*: 2020-01-28 | |||||||||||
Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | |||||||||||||
Full Title: Phase 3, open label, single arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-Padua) in adult male participants with moderately severe to severe he... | |||||||||||||
Medical condition: severe to moderately severe hemophilia B <=2% | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) FR (Ongoing) DE (Trial now transitioned) GR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2016-001464-11 | Sponsor Protocol Number: ALN-AT3SC-004 | Start Date*: Information not available in EudraCT | ||||||||||||||||
Sponsor Name:Alnylam Pharmaceuticals, Inc. | ||||||||||||||||||
Full Title: ATLAS-A/B: A Phase 3 study to evaluate the efficacy and safety of fitusiran in patients with hemophilia A or B, without inhibitory antibodies to factor VIII or IX | ||||||||||||||||||
Medical condition: Hemophilia A or Hemophilia B | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: IE (Prematurely Ended) BG (Completed) HU (Completed) ES (Prematurely Ended) PT (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Not Authorised) IT (Completed) Outside EU/EEA | ||||||||||||||||||
Trial results: View results |
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