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Clinical trials for Vonicog OR Veyvondi OR Vonvendi

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    7 result(s) found for: Vonicog OR Veyvondi OR Vonvendi. Displaying page 1 of 1.
    EudraCT Number: 2018-003453-16 Sponsor Protocol Number: SHP677-304 Start Date*: 2019-07-31
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PHASE 3B, PROSPECTIVE, OPEN-LABEL, UNCONTROLLED, MULTICENTER STUDY ON LONGTERM SAFETY AND EFFICACY OF rVWF IN PEDIATRIC AND ADULT SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE (VWD)
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DE (Completed) ES (Completed) AT (Completed) IT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003304-13 Sponsor Protocol Number: TAK-577-3001 Start Date*: Information not available in EudraCT
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis with rVWF in Children Diagnosed With Severe von Willebrand disease
    Medical condition: severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) NO (Completed) SE (Prematurely Ended) ES (Trial now transitioned) FR (Trial now transitioned) AT (Prematurely Ended) NL (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001477-33 Sponsor Protocol Number: 071102 Start Date*: 2016-12-01
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleed...
    Medical condition: Hereditary severe von Willebrand Disease in children
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) IT (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) CZ (Completed) ES (Trial now transitioned) FR (Trial now transitioned) DE (Completed) NL (Completed) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2016-001478-14 Sponsor Protocol Number: 071301 Start Date*: Information not available in EudraCT
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PROSPECTIVE, PHASE 3, OPEN LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE
    Medical condition: Hereditary severe von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    19.0 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) CZ (Completed) NL (Completed) ES (Completed) DE (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-003575-38 Sponsor Protocol Number: 071101 Start Date*: 2015-01-07
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A PHASE 3 PROSPECTIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF rVWF WITH OR WITHOUT ADVATE IN ELECTIVE SURGICAL PROCEDURES IN SUBJECTS WITH SEVERE VON WILLEBRAND DISEASE
    Medical condition: Hereditary severe von Willebrand Disease in adult patients who will undergo major and minor elective surgical procedures
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) IT (Completed) CZ (Completed) GB (Completed) NL (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-024108-84 Sponsor Protocol Number: 071001 Start Date*: 2011-10-31
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE
    Medical condition: Von Willebrand Disease
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10047715 Von Willebrand's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) AT (Completed) NL (Completed) BE (Completed) BG (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-001631-46 Sponsor Protocol Number: NL65876.078.18 Start Date*: 2019-02-14
    Sponsor Name:Erasmus University Medical Center
    Full Title: Implementation of pharmacokinetic-guided dosing of DDAVP and VWF-containing concentrates in von Willebrand disease
    Medical condition: Von Willebrand disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
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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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