- 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.
Displaying page 2 of 5.
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: 2008-006465-85 | Sponsor Protocol Number: BENEFIX | Start Date*: 2009-09-10 | |||||||||||
Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI | |||||||||||||
Full Title: Pharmacokinetic evaluation of a new formulation of recombinant factor IX (BeneFIX) in the italian population with severe or moderate B haemophilia previously treated. | |||||||||||||
Medical condition: Patients with severe or moderate B Haemophilia, previously treated with rFIX. | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-000996-19 | Sponsor Protocol Number: MAA-304 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Catalyst Biosciences, Inc. | |||||||||||||
Full Title: Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (Activated) For On-Demand Treatment and Control of Bleeding Episodes in Subjects with Haemophilia A or Haemophilia... | |||||||||||||
Medical condition: Marzeptacog alfa (activated) (MarzAA), a novel activated recombinant Factor VII (rFVIIa) variant, is being developed by Catalyst Biosciences to address the unmet need in haemophilia and other bleed... | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) HU (Prematurely Ended) PL (Prematurely Ended) DK (Prematurely Ended) BG (Prematurely Ended) IT (Prematurely Ended) | |||||||||||||
Trial results: View results |
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 |
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: 2013-003240-23 | Sponsor Protocol Number: 967908487 | Start Date*: 2013-12-09 | |||||||||||
Sponsor Name:St. James' Hospital | |||||||||||||
Full Title: PERSONALising Factor VIII prophylaxis regimens: Efficacy of standard versus pharmacokinetically based regimens in adult patients with severe Haemophilia A (PERSONAL trial) | |||||||||||||
Medical condition: Severe Haemophilia A | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: IE (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2005-005711-17 | Sponsor Protocol Number: AGT4HB | Start Date*: 2009-09-25 | ||||||||||||||||
Sponsor Name:St. Jude Children’s Research Hospital | ||||||||||||||||||
Full Title: AN OPEN LABEL DOSE-ESCALATION STUDY OF A SELF COMPLEMENTARY ADENO-ASSOCIATED VIRAL VECTOR (scAAV2/8-LP1-hFIXco) FOR GENE TRANSFER IN SUBJECTS WITH HEMOPHILIA B | ||||||||||||||||||
Medical condition: Gene therapy for Haemophilia B | ||||||||||||||||||
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Population Age: Adults | Gender: Male | |||||||||||||||||
Trial protocol: GB (Temporarily Halted) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2005-000891-42 | Sponsor Protocol Number: NN1731-1668 | Start Date*: 2005-09-07 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A randomised, open-label, multi-centre trial investigating the intra-subject variability of ROTEM® and TEG® parameters following two intravenous administrations of the same dose of activated recomb... | |||||||||||||
Medical condition: Haemophilia | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2011-000323-33 | Sponsor Protocol Number: BAY86-6150,IMPACT15534 | Start Date*: 2012-09-25 | ||||||||||||||||
Sponsor Name:Bayer HealthCare AG | ||||||||||||||||||
Full Title: A Phase 2/3, multicenter, open-label clinical study to assess the safety and efficacy of BAY86-6150 in subjects with hemophilia A or B with inhibitors, composed of 2 Parts (A & B). Part A: Sequenti... | ||||||||||||||||||
Medical condition: Subjects with hemophilia A or B with inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | |||||||||||||||||
Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) DK (Completed) IT (Prematurely Ended) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2019-002854-22 | Sponsor Protocol Number: UGA2014-01 | Start Date*: 2020-01-03 | ||||||||||||||||
Sponsor Name:Aryogen Pharmed | ||||||||||||||||||
Full Title: A RANDOMIZED, MULTICENTER, DOUBLE BLIND CLINICAL TRIAL COMPARING PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY OF A BIOSIMILAR EPTACOG ALFA (ARYOSEVEN) AND NOVOSEVEN®, IN PATIENTS WITH HAEMOPHILIA A ... | ||||||||||||||||||
Medical condition: HAEMOPHILIA A OR B WITH INHIBITORS | ||||||||||||||||||
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Population Age: Adults | Gender: Male | |||||||||||||||||
Trial protocol: BG (Prematurely Ended) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2011-006032-23 | Sponsor Protocol Number: CSL654_3002 | Start Date*: 2012-07-20 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: A Phase III Open-label, Multicenter, Pharmacokinetics, Safety, and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Previously Treated Children ... | |||||||||||||
Medical condition: Prophylaxis and treatment of bleeding episodes in previously treated children with congenital FIX deficiency (hemophilia B) | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: AT (Completed) ES (Completed) CZ (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-001885-27 | Sponsor Protocol Number: B7841002 | Start Date*: 2017-05-09 | ||||||||||||||||||||||||||
Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | ||||||||||||||||||||||||||||
Full Title: A MULTICENTER, OPEN-LABEL, MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF SUBCUTANEOUS OR INTRAVENOUS PF-06741086 IN SUBJECT... | ||||||||||||||||||||||||||||
Medical condition: Severe hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). | ||||||||||||||||||||||||||||
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Population Age: Adults | Gender: Male | |||||||||||||||||||||||||||
Trial protocol: PL (Completed) ES (Completed) FR (Completed) BG (Completed) HR (Completed) | ||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2009-016719-39 | Sponsor Protocol Number: 050901 | Start Date*: 2010-04-07 | |||||||||||
Sponsor Name:Baxter Innovations GmbH | |||||||||||||
Full Title: IMMUNINE – Purified Factor IX Concentrate Virus-Inactivated: A Phase IV, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors i... | |||||||||||||
Medical condition: To expose up to 50 patients aged 12-64 years, and approximately 20 pediatric patients up to 11 years of age with severe or moderately severe hemophilia B to IMMUNINE for a period of approximately 2... | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: CZ (Completed) BG (Completed) PL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2011-002415-28 | Sponsor Protocol Number: CSL654_3001 | Start Date*: 2012-01-19 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B | |||||||||||||
Medical condition: Hemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) AT (Completed) ES (Completed) IT (Completed) BG (Completed) | |||||||||||||
Trial results: View results |
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 (Prematurely Ended) DE (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2010-018477-38 | Sponsor Protocol Number: CSL654_2001 | Start Date*: 2010-11-15 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects with Hemophilia B. | |||||||||||||
Medical condition: Prophylaxis and treatment of bleeding episodes in subjects with congenital Factor IX (FIX) deficiency (Hemophilia B) | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) AT (Completed) ES (Completed) GB (Completed) IT (Completed) FR (Ongoing) | |||||||||||||
Trial results: View results |
EudraCT Number: 2011-006294-26 | Sponsor Protocol Number: 021101 | Start Date*: 2013-04-07 | ||||||||||||||||
Sponsor Name:Baxter Innovations GmbH | ||||||||||||||||||
Full Title: A Phase 3, Prospective, Open-label, Randomized Study to Evaluate Safety and Efficacy of Recombinant Activated FVII BI (rFVIIa BI) in the Treatment of Acute Bleeding Episodes per an On-demand Regime... | ||||||||||||||||||
Medical condition: Hemophilia A or B with FVIII or FIX inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | |||||||||||||||||
Trial protocol: ES (Completed) BE (Completed) PL (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2015-000958-38 | Sponsor Protocol Number: LFB-FVIIa-007-14 | Start Date*: 2016-01-06 | ||||||||||||||||
Sponsor Name:LFB USA, Inc. | ||||||||||||||||||
Full Title: A Phase III Study on the Safety, Pharmacokinetics, and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Pediatric Patients from birth to <12 years old with Inhibit... | ||||||||||||||||||
Medical condition: Congenital Hemophilia A or B patients with inhibitors to Factor VIII or Factor IX | ||||||||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male | |||||||||||||||||
Trial protocol: CZ (Completed) BG (Completed) IT (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2016-004087-19 | Sponsor Protocol Number: ALN-AT3SC-009 | Start Date*: 2017-08-25 | ||||||||||||||||
Sponsor Name:Alnylam Pharmaceuticals, Inc. | ||||||||||||||||||
Full Title: ATLAS-PPX trial: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in hemophilia A and B patients previously receiving factor or bypassing a... | ||||||||||||||||||
Medical condition: Hemophilia A or Hemophilia B | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: ES (Prematurely Ended) IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Not Authorised) IT (Completed) Outside EU/EEA | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2012-001309-26 | Sponsor Protocol Number: CSL689_2001 | Start Date*: 2015-11-09 | ||||||||||||||||
Sponsor Name:CSL Behring GmbH | ||||||||||||||||||
Full Title: A multicenter, open-label, multiple-dose, dose escalation study to investigate the pharmacokinetics, efficacy, and safety of rVIIa-FP (CSL689) in subjects with hemophilia (A or B) and inhibitors. | ||||||||||||||||||
Medical condition: Hemophilia A with inhibitors, Hemophilia B with inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | |||||||||||||||||
Trial protocol: DE (Completed) GB (Prematurely Ended) ES (Prematurely Ended) IT (Prematurely Ended) | ||||||||||||||||||
Trial results: View results |
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