- Trials with a EudraCT protocol (284)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
284 result(s) found for: hemophilia OR haemophilia.
Displaying page 9 of 15.
| EudraCT Number: 2013-003742-16 | Sponsor Protocol Number: IB1001-04 | Start Date*: 2014-04-29 | |||||||||||
| Sponsor Name:Cangene Europe Limited | |||||||||||||
| Full Title: Pharmacokinetics, Safety and Efficacy of Recombinant Factor IX Product, IB1001, in Patients with Severe Hemophilia B | |||||||||||||
| Medical condition: Severe Hemophilia B | |||||||||||||
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| Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
| Trial protocol: GB (Prematurely Ended) | |||||||||||||
| 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: 2026-000042-29 | Sponsor Protocol Number: YO39309 | Start Date*: 2026-02-12 | ||||||||||||||||
| Sponsor Name:F. Hoffmann-La Roche Ltd | ||||||||||||||||||
| Full Title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus No Prophylaxis in Hemophilia A Patients | ||||||||||||||||||
| Medical condition: Hemophilia A with or without Factor VIII inhibitors | ||||||||||||||||||
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| Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |||||||||||||||||
| Trial protocol: Outside EU/EEA | ||||||||||||||||||
| Trial results: (No results available) | ||||||||||||||||||
| 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: 2015-003027-61 | Sponsor Protocol Number: B1821048 | Start Date*: 2015-12-23 |
| Sponsor Name:Pfizer Inc. | ||
| Full Title: An open-label, single dose pharmacokinetic study of BeneFIX (nonacog alfa, recombinant factor IX) in male Chinese subjects with haemophilia B. | ||
| Medical condition: Haemophilia B | ||
| Disease: | ||
| Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male | |
| Trial protocol: Outside EU/EEA | ||
| Trial results: View results | ||
| EudraCT Number: 2006-005575-17 | Sponsor Protocol Number: 3082B2-313-WW | Start Date*: 2008-04-07 |
| Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc. | ||
| Full Title: An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the , Efficacy, Safety and Pharmacokinetics of B Domain Deleted Recombinant Factor VIII Albumin Free (ReFacto AF) in Child... | ||
| Medical condition: Younger Male Haemophilia A patients < 6 years of age with moderately severe to severe hemophilia A (FVIII activity =< 2%), with previous FVIII replacement therapy experience (>=50 exposure days). ... | ||
| Disease: | ||
| Population Age: Infants and toddlers, Children, Under 18 | Gender: Male | |
| Trial protocol: ES (Completed) DE (Completed) AT (Completed) IT (Completed) | ||
| Trial results: View results | ||
| EudraCT Number: 2009-016720-31 | Sponsor Protocol Number: 250901 | Start Date*: 2010-06-09 | |||||||||||
| Sponsor Name:Baxter Innovations GmbH [...] | |||||||||||||
| Full Title: BAX 326 (recombinant Factor IX): A Phase 1/3 Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, Immunogenicity in Previously Treated Patients with Severe (FIX... | |||||||||||||
| Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B. | |||||||||||||
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| Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
| Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) BG (Completed) SE (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2016-001094-33 | Sponsor Protocol Number: BO39182 | Start Date*: 2016-08-08 | ||||||||||||||||
| Sponsor Name:Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd. | ||||||||||||||||||
| Full Title: A MULTICENTER, OPEN-LABEL, PHASE III STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB GIVEN EVERY 4 WEEKS (Q4W) IN PATIENTS WITH HEMOPHILIA A | ||||||||||||||||||
| Medical condition: Hemophilia A | ||||||||||||||||||
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| Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |||||||||||||||||
| Trial protocol: ES (Temporarily Halted) PL (Completed) BE (Completed) | ||||||||||||||||||
| Trial results: View results | ||||||||||||||||||
| EudraCT Number: 2017-004805-42 | Sponsor Protocol Number: SB-FIX-1501 | Start Date*: 2018-06-05 | |||||||||||
| Sponsor Name:Sangamo Therapeutics, Inc. | |||||||||||||
| Full Title: A Phase I, Open-Label, Ascending Dose Study to Assess the Safety and Tolerability of AAV2/6 Factor IX Gene Therapy via Zinc Finger Nuclease (ZFN) mediated targeted integration of SB-FIX in Subjects... | |||||||||||||
| Medical condition: Severe Haemophilia B | |||||||||||||
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| Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
| Trial protocol: GB (GB - no longer in EU/EEA) | |||||||||||||
| Trial results: (No results available) | |||||||||||||
| EudraCT Number: 2017-004305-40 | Sponsor Protocol Number: CSL222-3001 | Start Date*: 2018-10-12 | |||||||||||
| Sponsor Name:CSL Behring LLC | |||||||||||||
| Full Title: Phase III, open-label, single-dose, multi-center multinational trial investigating a serotype 5 adeno-associated viral vector containing the Padua variant of a codon-optimized human factor IX gene ... | |||||||||||||
| Medical condition: Hemophilia B | |||||||||||||
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| Population Age: Adults, Elderly | Gender: Male | ||||||||||||
| Trial protocol: DK (Trial now transitioned) GB (GB - no longer in EU/EEA) IE (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) IT (Completed) | |||||||||||||
| Trial results: (No results available) | |||||||||||||
| EudraCT Number: 2017-003324-67 | Sponsor Protocol Number: BAY_1093884/19580 | Start Date*: 2018-06-22 | ||||||||||||||||||||||||||
| Sponsor Name:Bayer AG | ||||||||||||||||||||||||||||
| Full Title: Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors | ||||||||||||||||||||||||||||
| Medical condition: Hemophilia A or B | ||||||||||||||||||||||||||||
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| Population Age: Adults, Elderly | Gender: Male | |||||||||||||||||||||||||||
| Trial protocol: GB (Prematurely Ended) AT (Prematurely Ended) BG (Prematurely Ended) FR (Completed) HU (Prematurely Ended) IT (Prematurely Ended) | ||||||||||||||||||||||||||||
| Trial results: View results | ||||||||||||||||||||||||||||
| EudraCT Number: 2011-003539-68 | Sponsor Protocol Number: 2011/090/HP | Start Date*: 2012-02-09 | |||||||||||
| Sponsor Name:CHU-HOPITAUX DE ROUEN | |||||||||||||
| Full Title: ETUDE PROSPECTIVE RANDOMISEE COMPARATIVE PREDNISONE/ CYCLOPHOSPHAMIDE VERSUS PREDNISONE/ RITUXIMAB AU COURS DE L'HEMOPHILIE ACQUISE | |||||||||||||
| Medical condition: | |||||||||||||
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| Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
| Trial protocol: FR (Completed) | |||||||||||||
| Trial results: (No results available) | |||||||||||||
| EudraCT Number: 2015-001486-67 | Sponsor Protocol Number: 101HEMB01 | Start Date*: 2016-07-21 | |||||||||||
| Sponsor Name:Dimension Therapeutics, Inc. | |||||||||||||
| Full Title: A Phase I/II Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) rh10-Mediated Gene Transfer of Human Factor IX in Adults With Moderate/Severe to Severe Hemophilia B | |||||||||||||
| Medical condition: Moderate/severe to severe hemophilia B | |||||||||||||
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| Population Age: Adults, Elderly | Gender: Male | ||||||||||||
| Trial protocol: GB (Completed) BG (Prematurely Ended) | |||||||||||||
| 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: 2010-024190-39 | Sponsor Protocol Number: IB1001-02 | Start Date*: 2011-06-20 | |||||||||||
| Sponsor Name:Aptevo Europe Limited | |||||||||||||
| Full Title: Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects with Hemophilia B | |||||||||||||
| Medical condition: Haemophilia B | |||||||||||||
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| Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: GB (Completed) PL (Completed) | |||||||||||||
| Trial results: (No results available) | |||||||||||||
| 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: 2011-000413-39 | Sponsor Protocol Number: 251002 | Start Date*: 2011-10-06 | |||||||||||
| Sponsor Name:Baxter Innovations GmbH | |||||||||||||
| Full Title: BAX 326 (recombinant factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX level < 1%) or Moderately Severe (FIX level ... | |||||||||||||
| Medical condition: Previously treated patients with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B undergoing surgical or other invasive procedures | |||||||||||||
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| Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
| Trial protocol: GB (Completed) CZ (Completed) SE (Completed) BG (Completed) PL (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2011-002437-19 | Sponsor Protocol Number: 251101 | Start Date*: 2011-10-28 | |||||||||||
| Sponsor Name:Baxter Innovations GmbH | |||||||||||||
| Full Title: BAX326 (RECOMBINANT FACTOR IX): A PHASE 2/3 PROSPECTIVE, UNCONTROLLED, MULTICENTER STUDY EVALUATING PHARMACOKINETICS, EFFICACY, SAFETY, AND IMMUNOGENICITY IN PREVIOUSLY TREATED PEDIATRIC PATIENTS W... | |||||||||||||
| Medical condition: Pediatric previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX level ≤ 2%) hemophilia B. | |||||||||||||
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| Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||
| Trial protocol: GB (Completed) BG (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: 2013-003262-13 | Sponsor Protocol Number: CSL627_3001 | Start Date*: 2014-09-30 | |||||||||||
| Sponsor Name:CSL Behring GmbH | |||||||||||||
| Full Title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects with Severe Hemophilia A | |||||||||||||
| Medical condition: Hemophilia A Severe hemophilia A | |||||||||||||
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| Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
| Trial protocol: IT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) HU (Completed) ES (Completed) NL (Completed) AT (Completed) PL (Completed) PT (Completed) IE (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
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