- Trials with a EudraCT protocol (181)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (13)
181 result(s) found for: Hemophilia B.
Displaying page 1 of 10.
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: 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 (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2016-002396-99 | Sponsor Protocol Number: NN7170-4213 | Start Date*: 2016-10-20 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: Safety, tolerability, and pharmacokinetics study of single and multiple subcutaneous doses of turoctocog alfa pegol in patients with haemophilia A | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: AT (Completed) DE (Completed) BG (Completed) FR (Completed) GB (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-004106-15 | Sponsor Protocol Number: 3082B2-3316 | Start Date*: 2015-04-03 | |||||||||||
Sponsor Name:Wyeth Pharmaceutical Co., Ltd | |||||||||||||
Full Title: An Evaluation of the Safety and Efficacy of On-Demand Treatment with Xyntha (B-Domain Deleted Recombinant Factor VIII, Albumin Free) in Chinese Subjects with Hemophilia A | |||||||||||||
Medical condition: Hemophilia A | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
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: 2013-004779-11 | Sponsor Protocol Number: RB-FVIIa-006-13 | Start Date*: 2014-07-03 | ||||||||||||||||
Sponsor Name:rEVO Biologics, Inc. | ||||||||||||||||||
Full Title: A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa (Recombinant) in Congenital Hemophilia A or B Patients with Inhibitors to Factor VIII or IX | ||||||||||||||||||
Medical condition: Congenital haemophilia A or B patients with inhitors to Factor VIII or Factor IX | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: GB (Completed) BG (Completed) RO (Completed) PL (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2010-020224-22 | Sponsor Protocol Number: PTC124-GD-011-HEM | Start Date*: 2010-08-26 | ||||||||||||||||
Sponsor Name:PTC Therapeutics, Inc | ||||||||||||||||||
Full Title: A Phase 2a Study of Ataluren (PTC124) as an Oral Treatment for Nonsense-Mutation-Mediated Hemophilia A and B | ||||||||||||||||||
Medical condition: Nonsense-Mutation-Mediated Hemophilia A and B | ||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male | |||||||||||||||||
Trial protocol: FR (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2017-001271-23 | Sponsor Protocol Number: C0371004 | Start Date*: 2019-02-20 | ||||||||||||||||
Sponsor Name:Pfizer Inc. | ||||||||||||||||||
Full Title: AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE PROSPECTIVE EFFICACY AND SELECTED SAFETY DATA OF CURRENT FACTOR IX (FIX) OR FACTOR VIII (FVIII) PROPHYLAXIS REPLA... | ||||||||||||||||||
Medical condition: Moderately Severe To Severe Adult Hemophilia B Participants (FIX:C≤2%) Who Are Negative For Neutralizing Antibodies (NAb) To Adeno-Associated Virus Vector (AAV) Spark100. Moderately severe to sever... | ||||||||||||||||||
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Population Age: Adults | Gender: Male | |||||||||||||||||
Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) IE (Completed) DE (Ongoing) FR (Ongoing) ES (Ongoing) NL (Ongoing) | ||||||||||||||||||
Trial results: (No results available) |
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: 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 (Ongoing) DE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2008-006424-54 | Sponsor Protocol Number: NN7128-1907 | Start Date*: 2009-06-23 | ||||||||||||||||
Sponsor Name:Novo Nordisk A/S | ||||||||||||||||||
Full Title: An Exploratory Multi-Centre, Multi-National, Randomised, Double Blinded, Parallel Arm Trial Evaluating Safety, Pharmacokinetics and Dose-finding of prophylactic administration of Long Acting rFVIIa... | ||||||||||||||||||
Medical condition: Haemophilia A (Factor VIII) or B with Inhibitors | ||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | |||||||||||||||||
Trial protocol: SE (Completed) GB (Completed) FR (Completed) | ||||||||||||||||||
Trial results: View results |
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: 2018-003660-31 | Sponsor Protocol Number: B7841005 | Start Date*: 2020-09-07 | |||||||||||||||||||||
Sponsor Name:Pfizer Inc. | |||||||||||||||||||||||
Full Title: An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis | |||||||||||||||||||||||
Medical condition: Hemophilia A or B | |||||||||||||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male | ||||||||||||||||||||||
Trial protocol: DE (Prematurely Ended) FR (Ongoing) BG (Completed) GB (GB - no longer in EU/EEA) ES (Restarted) IE (Completed) HR (Completed) IT (Ongoing) | |||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2018-002880-25 | Sponsor Protocol Number: LTE15174 | Start Date*: 2019-03-08 | ||||||||||||||||
Sponsor Name:Genzyme Corporation | ||||||||||||||||||
Full Title: ATLAS-OLE: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients with Hemophilia A or B, with or 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 (Restarted) GB (GB - no longer in EU/EEA) DE (Completed) PT (Completed) HU (Ongoing) ES (Prematurely Ended) FR (Trial now transitioned) DK (Trial now transitioned) Outside EU/EEA IT (Ongoing) | ||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2008-001104-23 | Sponsor Protocol Number: CSLCT-BIO-07-47 | Start Date*: 2009-01-22 | |||||||||||
Sponsor Name:CSL Behring GmbH | |||||||||||||
Full Title: A Phase II, multicentre, double-blinded, randomised, cross-over study to evaluate efficacy, safety and pharmacokinetics of Biostate® in subjects with Haemophilia A. | |||||||||||||
Medical condition: Haemophilia A - a hereditary bleeding disorder characterised by a deficiency in the plasma protein known as coagulation Factor VIII (FVIII). | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2008-008435-29 | Sponsor Protocol Number: 3082B2-4433-WW | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Wyeth Pharmaceuticals Inc. Acting through its division Wyeth Research, a Pfizer Company | |||||||||||||
Full Title: A Non-Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of ReFacto AF in Previously Treated Pediatric Subjects Less Than Twelve Years of Age With Severe Hemophilia... | |||||||||||||
Medical condition: Severe hemophilia A (FVIII:C <1%) in male subjects <12 years of age. | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male | ||||||||||||
Trial protocol: FR (Completed) ES (Completed) IT (Completed) GR (Completed) CZ (Completed) SE (Completed) DK (Completed) FI (Completed) BG (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-003821-40 | Sponsor Protocol Number: NN7170-4345 | Start Date*: 2017-02-15 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: Evaluation of safety following Immune Tolerance Induction treatment with turoctocog alfa in patients with haemophilia A following inhibitor development in NN7170-4213 trial | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) AT (Completed) BG (Completed) DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2010-023921-39 | Sponsor Protocol Number: NN7008-3893 | Start Date*: 2011-04-27 | |||||||||||
Sponsor Name:Novo Nordisk A/S | |||||||||||||
Full Title: Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients with Haemophilia A | |||||||||||||
Medical condition: Haemophilia A | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male | ||||||||||||
Trial protocol: GB (Completed) | |||||||||||||
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) |
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