Flag of the European Union EU Clinical Trials Register Help

Clinical trials for BCX7353

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   43870   clinical trials with a EudraCT protocol, of which   7289   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    7 result(s) found for: BCX7353. Displaying page 1 of 1.
    EudraCT Number: 2017-003966-29 Sponsor Protocol Number: BCX7353-302 Start Date*: Information not available in EudraCT
    Sponsor Name:BioCryst Pharmaceuticals Inc.
    Full Title: A Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two dose levels of BCX7353 as an oral treatment for the prevention of attacks in...
    Medical condition: Hereditary angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) IE (Prematurely Ended) GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) DK (Completed) HU (Completed) CZ (Completed) AT (Completed) NL (Ongoing) BE (Completed) ES (Completed) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-001272-29 Sponsor Protocol Number: BCX7353-203 Start Date*: 2016-07-26
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: A randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of BCX7353 as a preventative...
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) HU (Completed) ES (Completed) AT (Completed) DK (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2017-003281-27 Sponsor Protocol Number: BCX7353-204 Start Date*: 2017-12-27
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: An Open-Label study to Evaluate the Long-Term Safety of Daily Oral BCX7353 in subjects with Type I and II Hereditary Angioedema
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) DK (Completed) AT (Completed) ES (Completed) SK (Completed) PL (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003923-74 Sponsor Protocol Number: BCX7353-201 Start Date*: 2015-12-23
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: A randomized, double-blind, 4 week, placebo-controlled, dose-ranging, parallel-group study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BCX7353 as a pre...
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001424-55 Sponsor Protocol Number: BCX7353-202 Start Date*: 2017-05-24
    Sponsor Name:BioCryst Pharmaceuticals Inc.
    Full Title: A randomized, double-blind, placebo-controlled, dose-ranging, study to evaluate the efficacy, safety and tolerability of single doses of BCX7353 as an acute attack treatment in subjects with heredi...
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) GB (Completed) AT (Completed) HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-005932-50 Sponsor Protocol Number: BCX7353-304 Start Date*: 2022-10-05
    Sponsor Name:BioCryst Pharmaceuticals, Inc.
    Full Title: A PHASE 3 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF BEROTRALSTAT PROPHYLAXIS IN CHILDREN WITH HEREDITARY ANGIOEDEMA WHO ARE 2 TO < 12 YEARS OF AGE
    Medical condition: Hereditary Angioedema (HAE)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Ongoing) IT (Ongoing) ES (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004230-37 Sponsor Protocol Number: BCX7353-312 Start Date*: Information not available in EudraCT
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: An open-label study to provide berotralstat access to subjects with type 1 and 2 hereditary angioedema who were previously enrolled in berotralstat studies
    Medical condition: Hereditary Angioedema
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10019860 Hereditary angioedema PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) CZ (Ongoing) SK (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Apr 30 15:12:46 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA