- Trials with a EudraCT protocol (283)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
283 result(s) found for: hemophilia OR haemophilia.
Displaying page 8 of 15.
EudraCT Number: 2015-002136-40 | Sponsor Protocol Number: 261203 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Baxalta Innovations GmbH | |||||||||||||
Full Title: Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 y... | |||||||||||||
Medical condition: Severe hemophilia A (FVIII <1%) | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) BG (Prematurely Ended) ES (Completed) CZ (Prematurely Ended) AT (Completed) HU (Completed) DE (Completed) NL (Prematurely Ended) BE (Completed) NO (Completed) DK (Completed) FI (Completed) IT (Completed) Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-004156-65 | Sponsor Protocol Number: 3090A1-3305 | Start Date*: 2015-04-06 | |||||||||||
Sponsor Name:Wyeth Pharmaceutical Co, Ltd. | |||||||||||||
Full Title: An Evaluation of the Safety and Efficacy of On-Demand Treatment with BeneFIX (Nonacog Alfa, Recombinant Factor IX) in Chinese Subjects with Hemophilia B | |||||||||||||
Medical condition: Hemophilia B | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-004430-38 | Sponsor Protocol Number: B1821059 | Start Date*: 2020-10-16 | |||||||||||
Sponsor Name:Pfizer, Inc. | |||||||||||||
Full Title: A SINGLE COUNTRY, MULTICENTER, OPEN-LABEL AND NON-RANDOMIZED CLINICAL TRIAL WITH NONACOG ALFA PROPHYLAXIS AND TREATMENT OF BLEEDING EPISODES IN PREVIOUSLY TREATED PATIENTS WITH MODERATELY-SEVERE TO... | |||||||||||||
Medical condition: Moderately severe to severe Hemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
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: 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: 2020-003371-18 | Sponsor Protocol Number: MAA-202 | Start Date*: 2021-03-30 | ||||||||||||||||
Sponsor Name:Catalyst Biosciences, Inc. | ||||||||||||||||||
Full Title: Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog alfa (activated) in Treatment of Episodic Bleeding in Subjects with Inherited Bleeding Disorders | ||||||||||||||||||
Medical condition: Factor VII deficiency, Glanzmann thrombasthenia (GT) and Hemophilia A with inhibitors on emicizumab prophylaxis (HAwI-E) | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |||||||||||||||||
Trial protocol: IT (Prematurely Ended) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2019-004480-48 | Sponsor Protocol Number: 20446 | Start Date*: 2021-12-14 | |||||||||||
Sponsor Name:Bayer AG | |||||||||||||
Full Title: A prospective, lead-in study to collect bleeding episodes, Factor VIII (FVIII) infusions, and patient-reported outcomes in patients with hemophilia A | |||||||||||||
Medical condition: Hemophilia A | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: ES (Prematurely Ended) NL (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-000662-29 | Sponsor Protocol Number: 270-203 | Start Date*: 2018-02-01 | |||||||||||
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 Residual FVIII Levels ≤ 1... | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2004-002648-88 | Sponsor Protocol Number: 3090A-101795 | Start Date*: 2005-11-17 |
Sponsor Name:Wyeth Pharmaceuticals | ||
Full Title: In vitro evaluation of allergic reactions in hemophilia B subjects who have exhibited a systemic allergic response after exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX) | ||
Medical condition: Hemophilia B | ||
Disease: | ||
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |
Trial protocol: GB (Completed) DE (Completed) FR (Ongoing) | ||
Trial results: (No results available) |
EudraCT Number: 2012-002554-23 | Sponsor Protocol Number: GENA-05 | Start Date*: 2013-02-19 | |||||||||||
Sponsor Name:OCTAPHARMA AG | |||||||||||||
Full Title: Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A | |||||||||||||
Medical condition: Severe Haemophilia A | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) PL (Completed) DE (Completed) ES (Completed) FR (Completed) PT (Completed) SI (Completed) HR (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-004434-42 | Sponsor Protocol Number: BAY94-9027/15912 | Start Date*: 2013-04-15 | ||||||||||||||||
Sponsor Name:Bayer AG | ||||||||||||||||||
Full Title: A multi-center, phase III, non-controlled, open-label trial to evaluate the pharmacokinetics, safety, and efficacy of BAY 94-9027 for prophylaxis and treatment of bleeding in previously treated chi... | ||||||||||||||||||
Medical condition: severe hemophilia A (<1% FVIII:C) | ||||||||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male | |||||||||||||||||
Trial protocol: GB (Completed) BE (Completed) IT (Completed) NL (Completed) LT (Completed) BG (Completed) Outside EU/EEA PL (Completed) AT (Completed) NO (Ongoing) ES (Completed) GR (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2022-002333-34 | Sponsor Protocol Number: CSL654_3004 | Start Date*: 2024-05-01 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: A Phase 3, Open-label, Multicenter, Pharmacokinetics, Efficacy, and Safety Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Chinese Su... | |||||||||||||
Medical condition: Hemophilia B | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2009-010172-21 | Sponsor Protocol Number: ENJOIH01 | Start Date*: 2009-08-27 | |||||||||||
Sponsor Name:Elena Santagostino | |||||||||||||
Full Title: An Investigator-sponsored study on rFVIIa prophylaxis in children with haemophilia A and inhibitors Estudio promovido por el investigador sobre profilaxis con rFVIIa en niños con hemofilia A e inh... | |||||||||||||
Medical condition: Hemofilia A | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: ES (Prematurely Ended) DE (Prematurely Ended) IT (Prematurely Ended) FR (Ongoing) PL (Prematurely Ended) | |||||||||||||
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 (Trial now transitioned) DE (Trial now transitioned) GR (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2007-004017-33 | Sponsor Protocol Number: 3090X1-4405 | Start Date*: 2008-04-17 | |||||||||||
Sponsor Name:Wyeth Pharmaceuticals France | |||||||||||||
Full Title: Reformulated BeneFIX efficacy and safety after conversion from a pdFIX. | |||||||||||||
Medical condition: Hemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-000852-24 | Sponsor Protocol Number: 15/0552 | Start Date*: 2017-08-23 | |||||||||||
Sponsor Name:University College London (UCL) | |||||||||||||
Full Title: A Phase I/II, Open label, Multicentre, Ascending Single Dose, Safety Study of a Novel Adeno-associated Viral Vector (FLT180a) in Patients With Haemophilia B | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-005489-37 | Sponsor Protocol Number: CSL654_3003 | Start Date*: 2014-07-11 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: A Phase 3b Open-label, Multicenter, Safety and Efficacy Extension 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: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) IT (Completed) CZ (Completed) BG (Completed) ES (Completed) AT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-003573-34 | Sponsor Protocol Number: 270-302 | Start Date*: 2018-02-23 |
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 at a dose of 4E13 vg/kg in Hemoph... | ||
Medical condition: Haemophilia A | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male | |
Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) FR (Completed) BE (Completed) IT (Prematurely Ended) | ||
Trial results: (No results available) |
EudraCT Number: 2007-005100-41 | Sponsor Protocol Number: IB1001-01 | Start Date*: 2009-03-16 | |||||||||||
Sponsor Name:Aptevo Europe Limited | |||||||||||||
Full Title: Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects with Haemophilia B | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) IT (Completed) FR (Ongoing) PL (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2015-005781-39 | Sponsor Protocol Number: 091501 | Start Date*: 2019-03-25 | ||||||||||||||||
Sponsor Name:Baxalta Innovations GmbH | ||||||||||||||||||
Full Title: A Phase 3b/4, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Pa... | ||||||||||||||||||
Medical condition: Hemophilia A or B with inhibitors | ||||||||||||||||||
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Population Age: Adults | Gender: Male, Female | |||||||||||||||||
Trial protocol: HR (Completed) RO (Completed) | ||||||||||||||||||
Trial results: View results |
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