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Clinical trials for McF 7

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    12 result(s) found for: McF 7. Displaying page 1 of 1.
    EudraCT Number: 2014-005115-16 Sponsor Protocol Number: FORMA-04 Start Date*: 2020-04-22
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, uncontrolled, Phase III study to assess the efficacy, safety, and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during an...
    Medical condition: Congenital fibrinogendeficiency
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-001759-17 Sponsor Protocol Number: FGTW2101 Start Date*: 2022-10-04
    Sponsor Name:Laboratoire français du Fractionnement et des Biotechnologies (LFB BIOTECHNOLOGIES)
    Full Title: A multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 study to assess the efficacy and safety of fibrinogen concentrate (FGTW) in the management of bleeding in patients und...
    Medical condition: Bleeding in patients undergoing complex cardiac surgery (involving CPB)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10022117 - Injury, poisoning and procedural complications 10017501 Functional disturbances following cardiac surgery LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004154-25 Sponsor Protocol Number: 984 Start Date*: 2013-06-25
    Sponsor Name:Biotest AG
    Full Title: A prospective, open-label, phase I/II study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenit...
    Medical condition: Patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016075 Factor I deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-004343-23 Sponsor Protocol Number: IG0902 Start Date*: 2018-03-20
    Sponsor Name:INSTITUTO GRIFOLS, S.A.
    Full Title: Studio per indagare le proprietà farmacocinetiche (per vedere quanto è attivo il farmaco di studio nel sangue e quanto tempo ci vuole per il farmaco di studio per uscire dal sangue), l'efficacia e ...
    Medical condition: Congenital Afibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004088-22 Sponsor Protocol Number: BI 3023_3001 Start Date*: 2009-09-22
    Sponsor Name:CSL BEHRING GmbH
    Full Title: Efficacy and safety of Fibrinogen Concentrate (Human) for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency
    Medical condition: Congenital fibrinogen deficiency ( afibrinogenemia, severe hypofibrinogenemia)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016075 LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002685-20 Sponsor Protocol Number: BI3023_3002 Start Date*: 2011-11-24
    Sponsor Name:CSL Behring GmbH
    Full Title: REPLACE (Randomized evaluation of fibrinogen versus placebo in complex cardiovascular surgery): a prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, phase III...
    Medical condition: Acute bleeding while undergoing aortic replacement surgery
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10049052 Aortic surgery NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FI (Completed) IT (Completed) AT (Completed) CZ (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-022923-31 Sponsor Protocol Number: FIinTIC Start Date*: Information not available in EudraCT
    Sponsor Name:Medizinische Universität Innsbruck / Univ.-Klinik für Allgem. u. Chirurg. Intensivmedizin
    Full Title: A multicenter double-blind, placebo controlled, randomized, pilot trial to assess the efficacy of pre-hospital administration of Fibrinogen Concentrate (FGTW) in trauma patients, presumed to bleed ...
    Medical condition: Trauma patients with major bleeding or occult bleeding who received volume replacement
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004866 10018988 Haemorrhage NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-003020-32 Sponsor Protocol Number: A011-16 Start Date*: 2022-02-03
    Sponsor Name:Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA
    Full Title: Phase 2, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of Sotatercept versus Placebo-Controlled for the Treatment of Combined Postcapillary and Precapillary Pulmonary ...
    Medical condition: Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037400 Pulmonary hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing) DE (Ongoing) ES (Ongoing) IT (Ongoing) SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001523-57 Sponsor Protocol Number: IM101179 Start Date*: 2011-06-10
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Resp...
    Medical condition: Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) DK (Completed) FR (Completed) ES (Completed) GB (Completed) IT (Completed) HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-000327-25 Sponsor Protocol Number: A6341009 Start Date*: 2008-05-19
    Sponsor Name:PFIZER S.A.
    Full Title: "ESTUDIO DE FASE 2A ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO Y DE GRUPOS PARALELOS DE CE-224,535, UN ANTAGONISTA DEL RECEPTOR P2X7, EN EL TRATAMIENTO DE LOS SIGNOS Y SÍNTOMAS DE LA ARTRITI...
    Medical condition: Artritis Reumatoide
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-003577-27 Sponsor Protocol Number: A6631007 Start Date*: 2006-12-01
    Sponsor Name:Pfizer Luxembourg SARL Branch Office Estonia
    Full Title: A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE...
    Medical condition: Treatment of rheumatoid arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    8.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) CZ (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-021184-32 Sponsor Protocol Number: GP13-201/GPN013A2301 Start Date*: 2010-11-30
    Sponsor Name:Hexal AG
    Full Title: A randomized, double-blind, controlled study to evaluate pharmacokinetics, pharmacodynamics, safety and efficacy of GP2013 and rituximab in patients with rheumatoid arthritis refractory or intolera...
    Medical condition: Refractory rheumatoid arthritis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10028395 - Musculoskeletal and connective tissue disorders 10039073 Rheumatoid arthritis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) ES (Completed) AT (Completed) IT (Completed) BE (Completed) EE (Completed) HU (Completed) PL (Completed) BG (Prematurely Ended) GB (Completed)
    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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