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Clinical trials for Bethesda unit

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    The EU Clinical Trials Register currently displays   44335   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).

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    49 result(s) found for: Bethesda unit. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2014-003895-21 Sponsor Protocol Number: 997HA309 Start Date*: 2020-11-01
    Sponsor Name:Biogen MA Inc
    Full Title: A Randomized, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) Manufactured at 15K Scale and at Different Vial Strengths...
    Medical condition: Hemophilia A
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-021781-29 Sponsor Protocol Number: BAY81-8973/13400 Start Date*: 2011-07-07
    Sponsor Name:Bayer HealthCare AG
    Full Title: A multicenter Phase III uncontrolled open-label trial to evaluate safety and efficacy of BAY 81-8973 in children with severe haemophilia A under prophylaxis therapy
    Medical condition: Severe Hemophilia-A (< 1% FVIII:C)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: HU (Completed) LT (Completed) SE (Completed) DK (Completed) IE (Completed) LV (Completed) BG (Completed) IT (Completed) PL (Completed) AT (Completed) ES (Completed) GB (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2021-003537-11 Sponsor Protocol Number: 19855 Start Date*: 2024-03-14
    Sponsor Name:Bayer Healthcare Company Limited
    Full Title: A Post Approval Commitment study to evaluate the efficacy, safety, and pharmacokinetics of KOVALTRY in Chinese children, adolescents/adults with severe hemophilia A.
    Medical condition: KOVALTRY, indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for: - Routine prophylaxis to reduce the frequency of bleeding episodes - On-demand treatmen...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    20.0 10042613 - Surgical and medical procedures 10071818 Bleeding prophylaxis LLT
    Population Age: Children, Adolescents, Under 18, Adults 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: 2009-012149-43 Sponsor Protocol Number: BAY81-8973/12954 Start Date*: 2010-09-06
    Sponsor Name:Bayer HealthCare AG
    Full Title: Ensayo aleatorizado, cruzado, abierto, en dos partes, para evaluar la farmacocinética, la eficacia y el perfil de seguridad de FVIII recombinante libre de proteínas plasmáticas formulado con sacaro...
    Medical condition: Hemofilia A severa (< 1% FVIII:C)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053753 Hemophilia A without inhibitors LLT
    12.1 10060612 Hemophilia A LLT
    12.1 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: ES (Completed) SE (Completed) GB (Completed) NO (Completed) DE (Completed) IT (Completed) AT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-020558-33 Sponsor Protocol Number: 997HA301 Start Date*: 2011-04-14
    Sponsor Name:Biogen Idec Hemophilia, Inc.
    Full Title: A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in ...
    Medical condition: Severe hemophilia A - defined as <1 IU/dL (<1%) endogenous FVIII
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10056493 Haemophilia A without inhibitors PT
    14.1 10010331 - Congenital, familial and genetic disorders 10053753 Hemophilia A without inhibitors LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10018937 Haemophilia A LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (Completed) FR (Ongoing) DE (Completed) BE (Completed) ES (Completed) AT (Completed) IT (Completed) PT (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: 2015-002136-40 Sponsor Protocol Number: 261203 Start Date*: Information not available in EudraCT
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 y...
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BG (Prematurely Ended) ES (Completed) CZ (Prematurely Ended) AT (Completed) HU (Completed) DE (Completed) NL (Prematurely Ended) BE (Completed) NO (Completed) DK (Completed) FI (Completed) IT (Completed) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-003456-20 Sponsor Protocol Number: ITN084AD Start Date*: 2020-02-17
    Sponsor Name:Division of Allergy, Immunology, and Transplantation; National Institute of Allergy and Infectious Disease
    Full Title: Grass Pollen Sublingual Tablet Immunotherapy plus Dupilumab for Induction of Tolerance in Adults with Moderate to Severe Seasonal Allergic Rhinitis.
    Medical condition: Moderate to Severe Seasonal Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004870 10039776 Seasonal allergic rhinitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-003076-36 Sponsor Protocol Number: 9HB02PED Start Date*: 2012-05-29
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: Open-label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Completed) IE (Completed) NL (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: 2007-003718-32 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
    EudraCT Number: 2008-000985-21 Sponsor Protocol Number: Bay14-2222/12800 Start Date*: 2009-12-07
    Sponsor Name:Bayer HealthCare Pharmaceuticals Inc
    Full Title: Randomized, controlled, parallel, prospective trial to evaluate the effect of secondary prophylaxis with rFVIII therapy in severe hemophilia A adult and/or adolescent subjects, as applicable, compa...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-004458-26 Sponsor Protocol Number: 12332 Start Date*: 2007-02-14
    Sponsor Name:Bayer Healthcare LLC
    Full Title: Randomized, comparative, open label treatment with double-blind placebo-controlled periods within treatment study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY...
    Medical condition: Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    8.1 10018937 Haemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) FR (Completed) AT (Prematurely Ended) CZ (Completed) BE (Completed) SK (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003013-18 Sponsor Protocol Number: 997HA307 Start Date*: 2014-04-23
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetics of 2 Vial Strengths of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in Previously Treated Subjects With S...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    18.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2022-004149-11 Sponsor Protocol Number: TAK-761-4009 Start Date*: 2023-07-27
    Sponsor Name:Takeda Biopharmaceuticals India Pvt. Ltd.
    Full Title: Phase 4, Multicenter, Prospective, Interventional, Post-Marketing Study in Hemophilia A Patients in India Receiving ADVATE as On-Demand or Prophylaxis Under Standard Clinical Practice
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000373-36 Sponsor Protocol Number: 997HA402 Start Date*: 2017-12-11
    Sponsor Name:Bioverativ Therapeutics Inc.
    Full Title: A Non-controlled, Open-Label, Multicenter, Study of Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Subjects with Inhibitors Undergoing the First ITI Treatment
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060613 Hemophilia A (Factor VIII) LLT
    20.0 100000011928 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male
    Trial protocol: ES (Completed) DE (Completed) BE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BG (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-012150-20 Sponsor Protocol Number: BAY81-8973/14319 Start Date*: 2011-02-02
    Sponsor Name:Bayer HealthCare AG
    Full Title: A phase II/III, randomized, cross-over, open-label trial to demonstrate superiority of prophylaxis over on-demand therapy in previously treated subjects with severe hemophilia A treated with plasma...
    Medical condition: Severe Hemophilia-A (< 1% FVIII:C)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10060613 Hemophilia A (Factor VIII) LLT
    13.1 10010331 - Congenital, familial and genetic disorders 10053753 Hemophilia A without inhibitors LLT
    13.1 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: CZ (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: 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
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