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Clinical trials for 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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   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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    230 result(s) found for: Factor VIII. Displaying page 1 of 12.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2004-001623-38 Sponsor Protocol Number: 060103 Start Date*: 2004-11-05
    Sponsor Name:Baxter AG
    Full Title: Phase 3B Recombinant Antihemophilic Factor Manufactured and Formulated without added Human or Animal Proteins (rAHF-PFM): Evaluation of Immunogenicity, Efficacy, and Safety in Previously Untreated ...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    9.1 10060612 Hemophilia A LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    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: 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: 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: 2016-003821-40 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
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Completed) AT (Completed) BG (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023666-46 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: 2008-001104-23 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: 2017-002281-46 Sponsor Protocol Number: NN7008-4304 Start Date*: 2018-02-20
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety of turoctocog alfa for prophylaxis and treatment of bleeding episodes in previously treated patients with moderate or severe Haemophilia A in India.
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-002456-24 Sponsor Protocol Number: 3082B2-4418 Start Date*: 2015-04-10
    Sponsor Name:Wyeth Research
    Full Title: A Post Authorization Safety Surveillance Study of Xyntha in Usual Care Settings
    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 Gender: Male
    Trial protocol: Outside EU/EEA
    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
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: 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
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    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: 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: 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: 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: 2013-004791-35 Sponsor Protocol Number: NN7008-4028 Start Date*: 2018-03-09
    Sponsor Name:Novo Nordisk A/S’
    Full Title: Efficacy and safety of turoctocog alfa for prophylaxis and treatment of bleeding episodes in previously treated Chinese patients with haemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    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: 2015-003685-88 Sponsor Protocol Number: B1831082 Start Date*: 2016-04-19
    Sponsor Name:Pfizer Inc.
    Full Title: An Open-label, Single Dose Pharmacokinetic Study Of Xyntha (moroctocog Alfa (af-cc), Recombinant Factor VIII) In Male Chinese Subjects With Hemophilia A
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: Outside EU/EEA
    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
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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