- Trials with a EudraCT protocol (572)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
572 result(s) found for: Thromboplastin.
Displaying page 1 of 29.
EudraCT Number: 2016-000765-22 | Sponsor Protocol Number: B1821052 | Start Date*: 2017-01-11 | |||||||||||
Sponsor Name:Pfizer, Inc. | |||||||||||||
Full Title: An Open-label, Single-arm, Post-authorization Pragmatic Clinical Trial On The Safety And Efficacy Of Benefix (nonacog Alfa, Recombinant Factor IX) In Subjects With Hemophilia B In Usual Care Settin... | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-002037-67 | Sponsor Protocol Number: IG404/1 | Start Date*: 2008-08-15 | |||||||||||
Sponsor Name:Grifols Biologicals Inc. | |||||||||||||
Full Title: EFFICACY AND SAFETY OF FACTOR IX (FIX) CONTAINED IN ALPHANINE® AND ITS PHARMACOKINETIC COMPARISON WITH BENEFIX® IN PATIENTS WITH SEVERE HEREDITARY HAEMOPHILIA B (Follow-up study of the trial IG404... | |||||||||||||
Medical condition: HEREDITARY HAEMOPHILIA B One single pharmacokinetic to compare the pharmacokinetic profile of BeneFIX with that of AlphaNine used by the same patients in a previous trial. | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-023069-24 | Sponsor Protocol Number: NN7999-3747 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Ha... | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: FR (Ongoing) NL (Completed) DE (Completed) GB (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2005-005246-40 | Sponsor Protocol Number: 3090A1-400-WW | Start Date*: 2007-01-30 | |||||||||||
Sponsor Name:Wyeth Pharmaceuticals Inc. - Global Medical Affairs | |||||||||||||
Full Title: A Multicenter, Open-Label Study to Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) in subjects with Severe ... | |||||||||||||
Medical condition: Male subjects, aged 6 years to 65 years, with a documented history of moderately severe or severe Hemophilia B (FIX:C≤2%) and with a minimum of 12 bleeding episodes, of which 6 must be joint bleeds... | |||||||||||||
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Population Age: Adults | Gender: Male | ||||||||||||
Trial protocol: HU (Completed) BE (Completed) IT (Completed) DE (Prematurely Ended) Outside EU/EEA | |||||||||||||
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: 2024-000583-38 | Sponsor Protocol Number: 70033093THR1011 | Start Date*: 2024-12-20 | |||||||||||
Sponsor Name:Janssen Research & Development, LLC | |||||||||||||
Full Title: Open-label, Multi-center, Single-dose Phase 1 Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Milvexian in Pediatric Patients From 28 Days to Less Than 18 Years of Age at Ris... | |||||||||||||
Medical condition: Thromboembolic Events | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
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: 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: 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 |
EudraCT Number: 2005-006186-14 | Sponsor Protocol Number: KB037 | Start Date*: 2007-09-10 | |||||||||||
Sponsor Name:KEDRION | |||||||||||||
Full Title: Open Label Phase II Evaluation of Pharmacokinetics, Efficacy, and Safety of Kedrion Human Plasma-derived Antihaemophilic Double Virus inactivated and Nanofiltered Factor IX Administered to Previous... | |||||||||||||
Medical condition: Severe or Moderately Severe Hemophilia B Patients | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: IT (Completed) | |||||||||||||
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: 2014-004155-32 | Sponsor Protocol Number: 3090A1-301 | Start Date*: 2015-04-06 | |||||||||||
Sponsor Name:Wyeth Research | |||||||||||||
Full Title: An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX ) in Children Less Than 6 Years of Age With Severe Hemophilia B | |||||||||||||
Medical condition: Hemophilia B | |||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
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: 2011-000520-15 | Sponsor Protocol Number: B1821010 | Start Date*: 2011-09-29 | |||||||||||
Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017 | |||||||||||||
Full Title: A MULTICENTER, OPEN LABEL STUDY TO COMPARE ON DEMAND TREATMENT TO A PROPHYLAXIS REGIMEN OF NONACOG ALFA (BENEFIX) IN SUBJECTS WITH MODERATELY SEVERE TO SEVERE HEMOPHILIA B (FIX:C ≤2%) | |||||||||||||
Medical condition: Hemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: PL (Completed) BG (Completed) GR (Completed) Outside EU/EEA | |||||||||||||
Trial results: View results |
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: 2012-004867-38 | Sponsor Protocol Number: NN7999-3895 | Start Date*: 2015-06-08 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B An open-label single-arm multicentre non-controlled phase 3a trial investigating safety and ... | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: DE (Completed) AT (Completed) ES (Ongoing) RO (Ongoing) IT (Prematurely Ended) | |||||||||||||
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: 2021-004947-25 | Sponsor Protocol Number: NN7999-4670 | Start Date*: 2023-07-12 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: A multi-centre, open-label trial evaluating efficacy, safety and pharmacokinetics of nonacog beta pegol when used for treatment and prophylaxis of bleeding episodes in Chinese patients with haemo... | |||||||||||||
Medical condition: Haemophilia B | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
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 |
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