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Clinical trials for Coagulation factor VIII

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    123 result(s) found for: Coagulation factor VIII. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    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
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Adults Gender: Male
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-004834-18 Sponsor Protocol Number: 060601 Start Date*: 2008-02-22
    Sponsor Name:Baxter Innovations GmbH
    Full Title: PHARMACOKINETIC COMPARISON OF ADVATE rAHF-PFM WITH RECOMBINATE rAHF IN PATIENTS WITH SEVERE HEMOPHILIA A: A PHASE IV, PROSPECTIVE, RANDOMIZED, CONTROLLED, CROSS-OVER, SINGLE CENTER STUDY
    Medical condition: The objective of this study is to further evaluate observations of decreased efficacy in subjects having been switched to Advate rAHF-PFM from Recombinate rAHF by comparing the pharmacokinetic para...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066439 Hemophilia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-002757-45 Sponsor Protocol Number: 11859 Start Date*: 2005-11-28
    Sponsor Name:Bayer HealthCare LLC/Biological Products
    Full Title: A prospective controlled study on the effect on bleeding events and joint function in young adults with severe hemophilia A after a 6 month prophylaxis treatment compared to on demand treatment
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    7.1 10018937 low
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    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).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-023242-69 Sponsor Protocol Number: GENA-11 Start Date*: 2011-05-31
    Sponsor Name:Octapharma AG
    Full Title: Clinical Study to Investigate the Long-Term Efficacy, Safety, and Immunogenicity of human-cl rhFVIII in Previously Treated Patients with Severe Haemophilia A – Extension Study to GENA-01
    Medical condition: Severe haemophilia A (FVIII:C <1%)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-002510-50 Sponsor Protocol Number: Biostate_4001 Start Date*: 2018-03-19
    Sponsor Name:CSL Behring GmbH
    Full Title: A low-interventional Multicentre Post-Authorisation Safety Study for Voncento/Biostate/Aleviate for Routine Prophylaxis, Treatment of Bleeding Events and/or Surgery in Male Subjects with Haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060612 Hemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001556-35 Sponsor Protocol Number: GENA-21 Start Date*: 2013-07-26
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of individually tailored prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe hae...
    Medical condition: Severe haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) SK (Completed) CZ (Completed) HU (Completed) BG (Completed) AT (Completed) ES (Prematurely Ended) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-002157-21 Sponsor Protocol Number: NN7008-3522 Start Date*: 2009-04-06
    Sponsor Name:NOVO NORDISK
    Full Title: A Multi-Centre, Multi-National, Open-Label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate in Subjects with Haemophilia A
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    12.0 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023666-46 Sponsor Protocol Number: F8VR-1006 Start Date*: 2011-12-13
    Sponsor Name:LFB BIOTECHNOLOGIES
    Full Title: EFFICACY AND SAFETY STUDY OF FACTANE 200 IU/ml ADMINISTERED BY CONTINUOUS INFUSION IN SEVERE HAEMOPHILIA A PATIENTS DURING MAJOR SURGICAL PROCEDURES
    Medical condition: HAEMOPHILIA A
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-007347-13 Sponsor Protocol Number: 060801 Start Date*: 2009-07-13
    Sponsor Name:Baxter Innovations GmbH
    Full Title: Advate (rAHF-PFM): Pharmacokinetic comparison of 3000 IU Advate (rAHF-PFM) (using one 3000 IU potency vial) with 3000 IU Advate (rAHF-PFM) (using two 1500 IU potency vials) in previously treated pa...
    Medical condition: severe hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060612 Hemophilia A LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-001336-65 Sponsor Protocol Number: CSL627_3002 Start Date*: 2013-11-27
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase III Open-label Pharmacokinetic, Efficacy and Safety Study of rVIII-SingleChain in a Pediatric Population with Severe Hemophilia A
    Medical condition: Congenital hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: HU (Prematurely Ended) DE (Completed) ES (Completed) NL (Completed) IT (Completed) PT (Completed) PL (Completed) AT (Completed) IE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-013227-28 Sponsor Protocol Number: F8VR-0624 Start Date*: 2009-09-08
    Sponsor Name:LFB BIOTECHNOLOGIES
    Full Title: A Double-Blind, Randomized, Crossover Study of the Recovery of FACTANE 100 versus 200 IU/ml followed by an Open-Label Safety Study of FACTANE 200 IU/ml in Previously Treated Patients With Severe (...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060612 Hemophilia A LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-003148-51 Sponsor Protocol Number: F13CD-1725 Start Date*: 2008-08-15
    Sponsor Name:Novo Nordisk A/S
    Full Title: A Multi-Centre, Open-Label, Single-Arm and Multiple Dosing Trial on Efficacy and Safety of Monthly Replacement Therapy with Recombinant Factor XIII (rFXIII) in Subjects with Congenital Factor XIII ...
    Medical condition: Congenital Factor XIII Deficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010432 Congenital deficiency of other clotting factors LLT
    9.1 10061992 Haemophilia LLT
    9.1 10009735 Coagulation disorders congenital HLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) DE (Completed) AT (Completed) ES (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-004435-22 Sponsor Protocol Number: AVI-40-3 Start Date*: 2005-12-13
    Sponsor Name:OCTAPHARMA AG
    Full Title: INCIDENCE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEAMOPHILIA A TREATED WITH OCTANATE
    Medical condition: Previously untreated patients with severe (FVIII:C<2%) haemophilia A, no inhibitor activity prior to admission, no concomitant therapy with Interferon, patients registered for regular treatment at ...
    Disease: Version SOC Term Classification Code Term Level
    8.0 10016080 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: CZ (Completed) FR (Not Authorised)
    Trial results: View results
    EudraCT Number: 2009-011186-88 Sponsor Protocol Number: ABB-09-001 Start Date*: 2009-09-08
    Sponsor Name:FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI
    Full Title: Desarrollo de inhibidores en pacientes no tratados previamente (PUP) o en pacientes mínimamente tratados con componentes sanguíneos (MBCTP) al ser expuestos a concentrados de derivados plasmáticos ...
    Medical condition: El estudio es un ensayo clínico abierto, aleatorizado, controlado, prospectivo, multicéntrico, internacional e independiente sobre la frecuencia de formación de inhibidores en pacientes no tratados...
    Disease: Version SOC Term Classification Code Term Level
    9 10018937 Haemophilia A LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Prematurely Ended) IT (Completed) PT (Completed) FR (Ongoing) DE (Completed) AT (Prematurely Ended) BE (Completed) GB (GB - no longer in EU/EEA) SK (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002393-23 Sponsor Protocol Number: CSL627_1001 Start Date*: 2012-01-10
    Sponsor Name:CSL Behring GmbH
    Full Title: A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Factor VIII (rFVIII; INN: octocog...
    Medical condition: Hemophilia A.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) SE (Completed) AT (Completed) IT (Completed) PL (Completed) GB (Completed) ES (Completed) HU (Completed) NL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2008-005945-46 Sponsor Protocol Number: NN7008-3568 Start Date*: 2010-01-18
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects with Haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: DE (Completed) ES (Completed) IT (Completed) GB (Completed) PL (Completed) LT (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2011-003072-37 Sponsor Protocol Number: 8HA01EXT Start Date*: 2012-01-18
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episode...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    19.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) BE (Completed) GB (Completed) DE (Completed) AT (Completed) ES (Completed) IT (Completed) IE (Completed) PL (Completed) NL (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.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    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: 2007-003718-32 Sponsor Protocol Number: BAY79-4980/12781 Start Date*: 2008-06-27
    Sponsor Name:Bayer HealthCare AG
    Full Title: Randomized, active-controlled, double-blind, parallel design study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY 79-4980 compared to three times-per-week proph...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060613 Hemophilia A (Factor VIII) LLT
    9.1 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) FR (Completed) NL (Completed) DK (Prematurely Ended) ES (Completed) BE (Completed) AT (Completed) GB (Completed) IT (Completed) NO (Completed)
    Trial results: View results
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