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Clinical trials for emicizumab

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   44039   clinical trials with a EudraCT protocol, of which   7319   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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    19 result(s) found for: emicizumab. Displaying page 1 of 1.
    EudraCT Number: 2019-002179-32 Sponsor Protocol Number: BO41423 Start Date*: 2019-10-15
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB IN PATIENTS WITH MILD OR MODERATE HEMOPHILIA A WITHOUT FVIII INHIBITORS
    Medical condition: Mild or moderate hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted) DE (Trial now transitioned) NL (Ongoing) PL (Completed) BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004430-42 Sponsor Protocol Number: AHA-EMI Start Date*: 2021-01-25
    Sponsor Name:GWT-TUD GmbH
    Full Title: Emicizumab in Patients with Acquired Hemophilia A: Multicenter, Single-Arm, Open-Label Clinical Trial
    Medical condition: Acquired Hemophilia A (AHA)
    Disease: Version SOC Term Classification Code Term Level
    22.1 100000004851 10053761 Acquired hemophilia with anti FVIII, XI, or XIII LLT
    20.0 100000004851 10053760 Acquired hemophilia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001094-33 Sponsor Protocol Number: BO39182 Start Date*: 2016-08-08
    Sponsor Name:Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd.
    Full Title: A MULTICENTER, OPEN-LABEL, PHASE III STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB GIVEN EVERY 4 WEEKS (Q4W) IN PATIENTS WITH HEMOPHILIA A
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10018938 Haemophilia A (Factor VIII) LLT
    19.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) PL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004366-25 Sponsor Protocol Number: MO39129 Start Date*: 2017-10-09
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A SINGLE-ARM, MULTICENTER PHASE IIIB CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF PROPHYLACTIC EMICIZUMAB IN HEMOPHILIA A PATIENTS WITH INHIBITORS
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Prematurely Ended) HU (Completed) ES (Completed) PL (Completed) FI (Completed) BE (Completed) SE (Completed) NL (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2020-003256-32 Sponsor Protocol Number: MO42245 Start Date*: 2021-04-14
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN INTERVENTIONAL OPEN-LABEL MULTICENTER PHASE IV STUDY TO EVALUATE THE IMPACT OF EMICIZUMAB ON HEALTH-RELATED QUALITY OF LIFE, PHYSICAL ACTIVITY, AND JOINT HEALTH IN PATIENTS WITH SEVERE HEMOPHILI...
    Medical condition: Severe hemophilia A without factor VIII inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: SE (Ongoing) NO (Ongoing) FI (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001733-12 Sponsor Protocol Number: MO41787 Start Date*: 2021-04-15
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IIIb, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SUBCUTANEOUS EMICIZUMAB IN PATIENTS FROM BIRTH TO 12 MONTHS OF AG...
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Ongoing) AT (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005092-13 Sponsor Protocol Number: MO42623 Start Date*: Information not available in EudraCT
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, OPEN-LABEL PHASE IV STUDY TO EVALUATE OVERALL HEALTH, PHYSICAL ACTIVITY, AND JOINT OUTCOMES, IN PARTICIPANTS AGED ≥ 13 AND < 70 YEARS WITH SEVERE OR MODERATE HEMOPHILIA A WITHOUT FVI...
    Medical condition: Severe or Moderate Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) DE (Trial now transitioned) ES (Ongoing) IT (Ongoing) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000072-17 Sponsor Protocol Number: BH30071 Start Date*: 2016-06-30
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS WITH...
    Medical condition: Haemophilia A without factor VIII inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) ES (Ongoing) DE (Completed) PL (Completed) FR (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2016-000073-21 Sponsor Protocol Number: BH29992 Start Date*: 2016-05-12
    Sponsor Name:Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd
    Full Title: A SINGLE-ARM, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ONCE WEEKLY SUBCUTANEOUS ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIA...
    Medical condition: Hemophilia A with Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-004039-10 Sponsor Protocol Number: NL81112.041.22 Start Date*: 2022-06-24
    Sponsor Name:UMC Utrecht - Van Creveldkliniek
    Full Title: Pharmacokinetic-guided dosing of emicizumab in congenital haemophilia A patients – The DosEmi study
    Medical condition: Congenital hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A 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: 2020-005916-23 Sponsor Protocol Number: ML39791 Start Date*: 2020-12-18
    Sponsor Name:Genentech, Inc.
    Full Title: A Phase IV, Multicenter, Single-Arm, Open-Label Study of Emicizumab Prophylaxis in Patients With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures
    Medical condition: Hemophilia A with or without inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053753 Hemophilia A without inhibitors LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002866-21 Sponsor Protocol Number: BH29884 Start Date*: 2016-01-11
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS ...
    Medical condition: Hemophilia A with Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10060612 Hemophilia A LLT
    19.1 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003427-38 Sponsor Protocol Number: MOTIVATE Start Date*: 2020-03-12
    Sponsor Name:HZRM – Hämophilie-Zentrum Rhein Main GmbH
    Full Title: MOdern Treatment of Inhibitor-PositiVe PATiEnts with Haemophilia A – An International Low-Interventional Pragmatic Investigator Initiated Trial
    Medical condition: Inhibitor-Positive patients with Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: DE (Trial now transitioned) NO (Trial now transitioned) SE (Trial now transitioned) FI (Trial now transitioned) HR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003213-34 Sponsor Protocol Number: 270-205 Start Date*: 2020-09-25
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 1/2 Safety, Tolerability, and Efficacy Study of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Active or Prior Inhibitors
    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: GB (GB - no longer in EU/EEA) IT (Ongoing) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-003371-18 Sponsor Protocol Number: MAA-202 Start Date*: 2021-03-30
    Sponsor Name:Catalyst Biosciences, Inc.
    Full Title: Phase 1/2 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Marzeptacog alfa (activated) in Treatment of Episodic Bleeding in Subjects with Inherited Bleeding Disorders
    Medical condition: Factor VII deficiency, Glanzmann thrombasthenia (GT) and Hemophilia A with inhibitors on emicizumab prophylaxis (HAwI-E)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10060612 Hemophilia A LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10016079 Factor VII deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002023-15 Sponsor Protocol Number: EFC16293 Start Date*: 2020-02-25
    Sponsor Name:Bioverativ Therapeutics Inc. (a Sanofi company)
    Full Title: Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTE...
    Medical condition: severe hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016080 Factor VIII deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) FR (Ongoing) BG (Completed) BE (Completed) GR (Completed) HU (Completed) NL (Completed) ES (Completed) Outside EU/EEA IT (Ongoing)
    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: (No results available)
    EudraCT Number: 2020-001048-24 Sponsor Protocol Number: NN7769-4514 Start Date*: 2021-05-18
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multinational, open-label, randomised, controlled trial to investigate efficacy and safety of NNC0365-3769 (Mim8) in adults and adolescents with haemophilia A with or without inhibitors.
    Medical condition: Haemophilia A Haemophilia A with inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10018938 Haemophilia A (Factor VIII) LLT
    20.0 10010331 - Congenital, familial and genetic disorders 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) SK (Completed) DK (Ongoing) DE (Completed) BE (Completed) AT (Completed) LV (Ongoing) LT (Ongoing) NL (Ongoing) PL (Completed) PT (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001271-23 Sponsor Protocol Number: C0371004 Start Date*: 2019-02-20
    Sponsor Name:Pfizer Inc.
    Full Title: AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE PROSPECTIVE EFFICACY AND SELECTED SAFETY DATA OF CURRENT FACTOR IX (FIX) OR FACTOR VIII (FVIII) PROPHYLAXIS REPLA...
    Medical condition: Moderately Severe To Severe Adult Hemophilia B Participants (FIX:C≤2%) Who Are Negative For Neutralizing Antibodies (NAb) To Adeno-Associated Virus Vector (AAV) Spark100. Moderately severe to sever...
    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: Adults Gender: Male
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) IE (Completed) DE (Completed) FR (Ongoing) ES (Ongoing) NL (Ongoing)
    Trial results: (No results available)
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