- Trials with a EudraCT protocol (44)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
44 result(s) found for: Factor X deficiency.
Displaying page 1 of 3.
| EudraCT Number: 2009-011145-18 | Sponsor Protocol Number: TEN01 | Start Date*: 2009-11-02 | |||||||||||
| Sponsor Name:Bio Products Laboratory Ltd | |||||||||||||
| Full Title: A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency | |||||||||||||
| Medical condition: Factor X deficiency | |||||||||||||
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| Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
| Trial protocol: GB (Completed) ES (Completed) DE (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| 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 (Trial now transitioned) | |||||||||||||
| Trial results: (No results available) | |||||||||||||
| EudraCT Number: 2005-000382-19 | Sponsor Protocol Number: BE1116_3001 | Start Date*: 2005-09-15 | |||||||||||
| Sponsor Name:ZLB Behring GmbH | |||||||||||||
| Full Title: Efficacy and tolerance of BERIPLEX® P/N in subjects with acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation | |||||||||||||
| Medical condition: Acquired deficiency of coagulation factors II, VII, IX and X due to oral anticoagulation requiring an immediate reversal of anticoagulant effect (i.e. emergency surgery or acute bleeding). | |||||||||||||
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| Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
| Trial protocol: DE (Completed) AT (Completed) HU (Completed) LT (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2010-019250-41 | Sponsor Protocol Number: 220901 | Start Date*: 2010-05-27 | |||||||||||
| Sponsor Name:Baxter Innovations GmbH | |||||||||||||
| Full Title: AN INTERNATIONAL, MULTI-CENTRE, PROSPECTIVE, OPEN-LABEL, NON-RANDOMISED, UNCONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROTHROMPLEX TOTAL IN ORAL ANTICOAGULANT REVERSAL IN PATIENTS WITH A... | |||||||||||||
| Medical condition: Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X) due to oral anticoagulant therapy with Vitamin K antagonists | |||||||||||||
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| Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
| Trial protocol: HU (Completed) AT (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2021-001079-18 | Sponsor Protocol Number: FLT180a-06 | Start Date*: 2022-04-27 | |||||||||||
| Sponsor Name:Freeline Therapeutics Ltd | |||||||||||||
| Full Title: A dose confirmation study of FLT180a (adeno-associated viral vector containing the Padua variant of a codon-optimized human Factor IX gene) in adult subjects with hemophilia B. | |||||||||||||
| Medical condition: Haemophilia B. | |||||||||||||
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| Population Age: Adults, Elderly | Gender: Male | ||||||||||||
| Trial protocol: AT (Prematurely Ended) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2010-023072-17 | Sponsor Protocol Number: NN7999-3775 | Start Date*: Information not available in EudraCT | |||||||||||
| Sponsor Name:Novo Nordisk A/S | |||||||||||||
| Full Title: Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure 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) AT (Completed) GR (Prematurely Ended) | |||||||||||||
| 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: 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 (Trial now transitioned) IT (Trial now transitioned) | ||||||||||||||||||
| Trial results: (No results available) | ||||||||||||||||||
| EudraCT Number: 2011-000826-31 | Sponsor Protocol Number: NN7999-3774 | Start Date*: 2012-08-24 | |||||||||||
| Sponsor Name:Novo Nordisk | |||||||||||||
| Full Title: Safety, Efficacy and Pharmacokinetics of NNC-0156- 0000-0009 (N9-GP) in Previously Treated Children with Haemophilia B | |||||||||||||
| Medical condition: Haemophilia B | |||||||||||||
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| Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male | ||||||||||||
| Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2015-002866-21 | Sponsor Protocol Number: BH29884 | Start Date*: 2016-01-11 | ||||||||||||||||
| 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 Inhibitors | ||||||||||||||||||
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| Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |||||||||||||||||
| Trial protocol: DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) PL (Completed) FR (Completed) IT (Completed) | ||||||||||||||||||
| 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 (Trial now transitioned) FR (Trial now transitioned) IT (Completed) ES (Restarted) | |||||||||||||
| Trial results: (No results available) | |||||||||||||
| EudraCT Number: 2008-000985-21 | Sponsor Protocol Number: Bay14-2222/12800 | Start Date*: 2009-12-07 | |||||||||||
| Sponsor Name:Bayer HealthCare Pharmaceuticals Inc | |||||||||||||
| Full Title: Randomized, controlled, parallel, prospective trial to evaluate the effect of secondary prophylaxis with rFVIII therapy in severe hemophilia A adult and/or adolescent subjects, as applicable, compa... | |||||||||||||
| Medical condition: Hemophilia A | |||||||||||||
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| Population Age: Adults | Gender: Male | ||||||||||||
| Trial protocol: BG (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2009-015086-31 | Sponsor Protocol Number: Ten03 | Start Date*: 2010-03-16 |
| Sponsor Name:Bio Products Laboratory Limited | ||
| Full Title: Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery | ||
| Medical condition: Factor X Deficiency | ||
| Disease: | ||
| Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |
| Trial protocol: GB (Prematurely Ended) ES (Prematurely Ended) | ||
| Trial results: View results | ||
| EudraCT Number: 2012-003093-98 | Sponsor Protocol Number: Ten02 | Start Date*: 2015-02-24 |
| Sponsor Name:Bio Products Laboratory Limited | ||
| Full Title: A Phase III Open, Multicentre Study to Confirm the Safety, Pharmacokinetics and Efficacy of BPL’s High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of... | ||
| Medical condition: Factor X Deficiency | ||
| Disease: | ||
| Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male, Female | |
| Trial protocol: GB (Completed) | ||
| 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: 2016-004366-25 | Sponsor Protocol Number: MO39129 | Start Date*: 2017-10-09 | ||||||||||||||||
| Sponsor Name:F. Hoffmann-La Roche Ltd | ||||||||||||||||||
| Full Title: A SINGLE-ARM, MULTICENTER PHASE IIIB CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF PROPHYLACTIC EMICIZUMAB IN HEMOPHILIA A PATIENTS WITH INHIBITORS | ||||||||||||||||||
| Medical condition: Hemophilia A | ||||||||||||||||||
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| Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |||||||||||||||||
| Trial protocol: PT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Prematurely Ended) HU (Completed) ES (Completed) PL (Completed) FI (Completed) BE (Completed) SE (Completed) NL (Completed) IT (Completed) RO (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: 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: 2008-007997-39 | Sponsor Protocol Number: B1831004(3082B2-4432-WW) | Start Date*: 2009-04-09 | |||||||||||
| Sponsor Name:Wyeth Pharmaceuticals, Inc. Acting through its division Wyeth Research, a Pfizer Company | |||||||||||||
| Full Title: A Postauthorization Safety Surveillance Study of Patients Switching to ReFacto AF From ReFacto or Other Factor VIII Products in Usual Care Settings | |||||||||||||
| Medical condition: Severe haemophilia A (FVIII:C <1%) in male patients ≥12 years of age with a treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products and transitioning to ReFa... | |||||||||||||
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| Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
| Trial protocol: DE (Completed) BE (Completed) ES (Completed) SE (Completed) AT (Completed) FI (Completed) DK (Completed) FR (Completed) IT (Completed) PT (Prematurely Ended) NL (Completed) GB (Completed) CZ (Completed) GR (Completed) HU (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
| EudraCT Number: 2010-021781-29 | Sponsor Protocol Number: BAY81-8973/13400 | Start Date*: 2011-07-07 | |||||||||||
| Sponsor Name:Bayer HealthCare AG | |||||||||||||
| Full Title: A multicenter Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 in children with severe haemophilia A under prophylaxis therapy | |||||||||||||
| Medical condition: Severe Hemophilia-A (< 1% FVIII:C) | |||||||||||||
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| Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
| Trial protocol: HU (Completed) LT (Completed) SE (Completed) DK (Completed) IE (Completed) LV (Completed) BG (Completed) IT (Completed) PL (Completed) AT (Completed) ES (Completed) GB (Completed) NO (Completed) | |||||||||||||
| Trial results: View results | |||||||||||||
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