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Clinical trials for Refacto

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   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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    18 result(s) found for: Refacto. Displaying page 1 of 1.
    EudraCT Number: 2005-000720-16 Sponsor Protocol Number: 3082B2-310-WW Start Date*: 2005-06-22
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals, Inc.
    Full Title: A Randomised, Two-way, Blinded, Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) with a Full-Length Recombinant Factor VIII...
    Medical condition: For all patients participating in the trial:Male subjects with severe or moderately severe hemophilia A (FVIII:C ≤ 2%) previously treated with ≥ 150 exposure days to any Factor VIII product.For pat...
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: HU (Completed) ES (Completed) DE (Completed) SE (Completed) FI (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    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...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    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: 2004-003727-12 Sponsor Protocol Number: 3082A-101711 Start Date*: 2005-05-09
    Sponsor Name:Wyeth Pharmaceuticals, Global Medical Affairs
    Full Title: A Single Dose, Randomized, 2-Period Crossover Study in Patients with Hemophilia A to Evaluate the Pharmacokinetics of Refacto(B-domain deleted recombinant human factor VIII (BDDrFVIII) and Advate (...
    Medical condition: Hemophilia A
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-001579-37 Sponsor Protocol Number: 3082B2-311-WW Start Date*: 2006-02-16
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals, Inc. Clinical Research and Development
    Full Title: An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
    Medical condition: Male subjects with hemophilia A (FVIII:C ≤2% confirmed at screening), previously treated with ≥ 150 exposure days to any Factor VIII product, undergoing elective major surgery that is anticipated t...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Prematurely Ended) AT (Completed) FR (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: 2008-008436-93 Sponsor Protocol Number: B1831006(3082B2-4434-WW) Start Date*: 2009-12-16
    Sponsor Name:Wyeth Pharmaceutical Inc. acting through its division Wyeth Research, a Pfizer Company
    Full Title: An Open-Label Study of the Safety and Efficacy of ReFacto AF in Previously Untreated Patients in Usual Care Settings
    Medical condition: Severe hemophilia A (FVIII:C <1%) in male subjects <6 years of age.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10018937 Haemophilia A LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: DE (Completed) FR (Completed) AT (Completed) ES (Completed) IT (Completed) SE (Completed) NL (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-005575-17 Sponsor Protocol Number: 3082B2-313-WW Start Date*: 2008-04-07
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: An Open-Label Study to Evaluate Prophylaxis Treatment, and to Characterize the , Efficacy, Safety and Pharmacokinetics of B Domain Deleted Recombinant Factor VIII Albumin Free (ReFacto AF) in Child...
    Medical condition: Younger Male Haemophilia A patients < 6 years of age with moderately severe to severe hemophilia A (FVIII activity =< 2%), with previous FVIII replacement therapy experience (>=50 exposure days). ...
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Completed) DE (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-000767-20 Sponsor Protocol Number: 2005-09-20 Start Date*: 2008-03-13
    Sponsor Name:Koagulationscentrum UMAS
    Full Title: Daglig profylax vid svår hemofili
    Medical condition: Hemofili
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-005103-41 Sponsor Protocol Number: 8200 Start Date*: 2005-12-05
    Sponsor Name:Anne Mette Hvas
    Full Title: Clot formation and clot stability in severe haemophilia A - effect of recombinant factor VIII and tranexamic acid.
    Medical condition: Severe haemophilia A
    Disease:
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001669-34 Sponsor Protocol Number: Start Date*: 2012-07-12
    Sponsor Name:Med. Univ. Wien, Univ. Klinik f. Kinder- u. Jugendheilkunde, Klin. Abt.f. Pädiatrische Kardiologie
    Full Title: Genetic Influence on the Pharmacokinetic Behavor of Factor VIII
    Medical condition: Haemophilia A under prophylactic Factor VIII Substitution
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: AT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000909-24 Sponsor Protocol Number: 201302-OPTICLOT Start Date*: 2013-08-29
    Sponsor Name:Erasmus MC
    Full Title: "OPTI-CLOT": Peri-Operative PharmacokineTIc-guided dosing of CLOTting factor in Hemophilia.
    Medical condition: Hemophillia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10066439 Hemophilia LLT
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-008378-29 Sponsor Protocol Number: 0808128 Start Date*: 2009-05-20
    Sponsor Name:CHU de Saint-Etienne
    Full Title: A survey on the success of inhibitor elimination using individualized concentrate selection and controlled immune tolerance induction
    Medical condition: patients with haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018937 Haemophilia A LLT
    9.1 10018938 Haemophilia A (Factor VIII) LLT
    9.1 10056492 Haemophilia A with anti factor VIII LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-001445-40 Sponsor Protocol Number: GreenGeneF_P3 Start Date*: 2013-01-09
    Sponsor Name:Green Cross Corporation
    Full Title: Determination of Safety, Efficacy, and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 years of age or older Diagnosed with Severe Hemophilia A
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) PL (Prematurely Ended) HR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-000219-24 Sponsor Protocol Number: 3082A-101342 Start Date*: 2005-04-28
    Sponsor Name:Wyeth Pharmaceuticals
    Full Title: A multicentre study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital haemophilia A who develop de novo factor VIII inhibitors while receiving fac...
    Medical condition: Haemophilia A is an X-linked recessive clotting disorder in which the clotting factor, factor VIII (FVIII), is deficient or inactive. Patients with low levels of FVIII have an increased tendency t...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed) DE (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003869-33 Sponsor Protocol Number: NL67754.078.18 Start Date*: 2019-05-07
    Sponsor Name:Erasmus University Medical Center
    Full Title: Implementation of pharmacokinetic-guided dosing of prophylaxis in hemophilia patients.
    Medical condition: Hemophilia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060614 Hemophilia B (Factor IX) LLT
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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: 2008-007016-15 Sponsor Protocol Number: RES.I.ST. NAÏVE Start Date*: 2008-12-24
    Sponsor Name:FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI
    Full Title: RANDOMISED STUDY OF FIRST CHOICE IMMUNOTOLERANCE INDUCTION IN PATIENTS WITH SEVERE TYPE A HAEMOPHILIA WITH INHIBITOR AT HIGH RISK OF FAILURE: COMPARISON OF INDUCTION OF IMMUNE TOLERANCE WITH FVIII ...
    Medical condition: SEVERE TYPE A HAEMOPHILIA
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010432 Congenital deficiency of other clotting factors LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: IT (Ongoing) ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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)
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