- Trials with a EudraCT protocol (86)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
86 result(s) found for: Haemophilia B With Inhibitors AND Haemophilia.
Displaying page 1 of 5.
EudraCT Number: 2018-004891-36 | Sponsor Protocol Number: NN7415-4307 | Start Date*: 2019-11-20 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B without inhibitors | ||||||||||||||||||
Medical condition: Haemophilia A Haemophilia B | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: DK (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) SK (Prematurely Ended) DE (Trial now transitioned) BG (Completed) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) PT (Trial now transitioned) HR (Completed) HU (Trial now transitioned) LT (Trial now transitioned) EE (Trial now transitioned) IT (Trial now transitioned) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-002641-37 | Sponsor Protocol Number: NN7415-4580 | Start Date*: Information not available in EudraCT | ||||||||||||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||||||||||||
Full Title: Efficacy and safety of once-weekly subcutaneous administration of concizumab prophylaxis in patients with haemophilia A and B, with or without inhibitors | ||||||||||||||||||||||||||||
Medical condition: Haemophilia A Haemophilia A with inhibitors Haemophilia B Haemophilia B with inhibitors | ||||||||||||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||||||||||||
Trial protocol: SE (Prematurely Ended) NL (Prematurely Ended) | ||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2020-001048-24 | Sponsor Protocol Number: NN7769-4514 | Start Date*: 2021-05-18 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors. | ||||||||||||||||||
Medical condition: Haemophilia A Haemophilia A with inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |||||||||||||||||
Trial protocol: IE (Completed) SK (Completed) DK (Completed) DE (Completed) BE (Completed) AT (Completed) LV (Completed) LT (Completed) FR (Completed) NL (Completed) PL (Completed) PT (Completed) IT (Completed) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2016-000510-30 | Sponsor Protocol Number: NN7415-4310 | Start Date*: 2017-06-08 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients with Inhibitors | ||||||||||||||||||
Medical condition: Haemophilia A with inhibitors Haemophilia B with inhibitors | ||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: SE (Completed) DK (Completed) GB (Completed) GR (Prematurely Ended) ES (Completed) AT (Completed) HR (Completed) IT (Completed) | ||||||||||||||||||
Trial results: View results |
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 (Completed) PL (Completed) IT (Completed) ES (Ongoing) PT (Completed) LT (Completed) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-004889-34 | Sponsor Protocol Number: NN7415-4311 | Start Date*: 2019-10-07 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: Efficacy and Safety of Concizumab prophylaxis in patients with haemophilia A or B with inhibitors | ||||||||||||||||||
Medical condition: Haemophilia A with inhibitors Haemophilia B with inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: DK (Trial now transitioned) SE (Trial now transitioned) AT (Completed) FR (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) SK (Completed) NO (Completed) BG (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) HR (Trial now transitioned) IT (Trial now transitioned) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-000504-11 | Sponsor Protocol Number: NN7415-4616 | Start Date*: 2022-04-05 | ||||||||||||||||||||||||||
Sponsor Name:NOVO NORDISK. S.P.A. | ||||||||||||||||||||||||||||
Full Title: Open-label study investigating efficacy, safety and pharmacokinetics of concizumab prophylaxis in children below 12 years with haemophilia A or B with or without inhibitors | ||||||||||||||||||||||||||||
Medical condition: Haemophilia A with or without inhibitors Haemophilia B with our without inhibitors | ||||||||||||||||||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male | |||||||||||||||||||||||||||
Trial protocol: IT (Trial now transitioned) NO (Trial now transitioned) GR (Trial now transitioned) SE (Trial now transitioned) LT (Trial now transitioned) EE (Completed) BG (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) | ||||||||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2016-000614-29 | Sponsor Protocol Number: NN7415-4255 | Start Date*: 2017-06-12 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients with Severe Haemophilia A without Inhibitors | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: SE (Temporarily Halted) DE (Completed) ES (Completed) FR (Completed) GB (GB - no longer in EU/EEA) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-023803-92 | Sponsor Protocol Number: NN1731-3562 | Start Date*: 2011-06-01 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: Efficacy and Safety of NNC 0078-0000-0007 in Treatment of Acute Bleeding Episodes in Patients with Congenital Haemophilia and Inhibitors | ||||||||||||||||||
Medical condition: Congenital Haemophilia and Inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: GB (Completed) AT (Completed) GR (Completed) PL (Completed) ES (Prematurely Ended) IT (Completed) HU (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2008-003960-20 | Sponsor Protocol Number: NN7008-3543 | Start Date*: 2009-06-26 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A Multi-Centre, Open-Label, Non-Controlled Trial on Safety and Efficacy of N8 in Prevention and Treatment of Bleeds in Previously Treated Subjects with Haemophilia A Sub-Trial: Safety and Efficacy ... | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) GB (Completed) ES (Completed) IT (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2006-004879-35 | Sponsor Protocol Number: NN1731-1804 | Start Date*: 2007-11-19 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: A multi-centre, randomised, double-blinded, controlled, dose-escalation trial on safety and efficacy of activated recombinant FVII analogue (NN1731) in the treatment of joint bleeds in congenital h... | ||||||||||||||||||
Medical condition: Haemophilia A with anti factor VIII and Haemophilia B with anti factor IX | ||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: GB (Completed) HU (Completed) IT (Prematurely Ended) FR (Completed) ES (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2013-005579-42 | Sponsor Protocol Number: CT-AMT-060-01 | Start Date*: 2015-03-20 | |||||||||||
Sponsor Name:uniQure biopharma B.V. | |||||||||||||
Full Title: A phase I/II, open-label, uncontrolled, single-dose, dose-ascending, multi-centre trial investigating an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) ... | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) DK (Completed) NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-000739-28 | Sponsor Protocol Number: CT-AMT-060-04_(CSL220_1002) | Start Date*: 2020-11-19 | |||||||||||
Sponsor Name:CSL Behring LLC | |||||||||||||
Full Title: A Phase I/IIb extension study assessing the long-term safety and efficacy of an adeno-associated viral vector containing a codon-optimized human factor IX gene (AAV5-hFIX) previously administered t... | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Trial now transitioned) DK (Prematurely Ended) NL (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2010-020113-85 | Sponsor Protocol Number: CSLCT-BIO-l0-67 | Start Date*: 2011-09-20 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: A Multicentre, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihaemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune To... | |||||||||||||
Medical condition: Male paediatric subjects with Haemophilia A who develped high titre antibodies to human coagulation Factor VIII | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Prematurely Ended) FR (Completed) AT (Completed) GR (Prematurely Ended) IT (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-006424-54 | Sponsor Protocol Number: NN7128-1907 | Start Date*: 2009-06-23 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of prophylactic administration of Long Acting rFVIIa... | ||||||||||||||||||
Medical condition: Haemophilia A (Factor VIII) or B with Inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | |||||||||||||||||
Trial protocol: SE (Completed) GB (Completed) FR (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2013-004779-11 | Sponsor Protocol Number: RB-FVIIa-006-13 | Start Date*: 2014-07-03 | ||||||||||||||||
Sponsor Name:rEVO Biologics, Inc. | ||||||||||||||||||
Full Title: A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients with Inhibitors to Factor VIII or IX | ||||||||||||||||||
Medical condition: Congenital haemophilia A or B patients with inhitors to Factor VIII or Factor IX | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: GB (Completed) BG (Completed) RO (Completed) PL (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2015-001919-13 | Sponsor Protocol Number: NN1731-4214 | Start Date*: 2016-03-17 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: Pharmacogenetic testing of saliva samples from patients with ≥5 exposure days to rFVIIa analogue in the adept™2 trial. Bio-specimen research study | ||||||||||||||||||
Medical condition: - Haemophilia A with inhibitors - Haemophilia B with inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | |||||||||||||||||
Trial protocol: RO (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2019-000465-20 | Sponsor Protocol Number: NN7769-4513 | Start Date*: 2019-12-16 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous doses of NNC0365-3769 (Mim8) in healthy subjects and in subjects with haemophilia A with or without f... | ||||||||||||||||||
Medical condition: Healthy volunteers (Haemophilia A with or without inhibitors) Haemophilia A Haemophilia A with inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) AT (Completed) BG (Completed) PL (Completed) IT (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2009-015112-18 | Sponsor Protocol Number: CSLCT-BIO-08-53 | Start Date*: 2011-11-30 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: A Phase III, Open-Label, Multicentre Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Biostate® in Paediatric Subjects with Haemophilia A. | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-023070-40 | Sponsor Protocol Number: NN7999-3773 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures in Patients with Haemophilia B | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: FR (Ongoing) GB (Completed) NL (Completed) DE (Completed) IT (Completed) ES (Completed) GR (Prematurely Ended) AT (Completed) | |||||||||||||
Trial results: View results |
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