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Clinical trials for cysteamine and cystic fibrosis

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   44352   clinical trials with a EudraCT protocol, of which   7379   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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    4 result(s) found for: cysteamine and cystic fibrosis. Displaying page 1 of 1.
    EudraCT Number: 2014-000284-40 Sponsor Protocol Number: 3/001/14 Start Date*: 2014-06-05
    Sponsor Name:University of Aberdeen [...]
    1. University of Aberdeen
    2. NHS Grampian
    Full Title: An open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis.
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001258-82 Sponsor Protocol Number: CFTRcysta1 Start Date*: 2013-09-12
    Sponsor Name:European Institute for Cystic Fibrosis Research (IERFC)
    Full Title: A phase II pilot clinical study of experimental research to evaluate the functional rescue of CFTR protein through proteostasis regulators
    Medical condition: Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II mutations
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004986-99 Sponsor Protocol Number: NBTCS02 Start Date*: 2017-01-11
    Sponsor Name:NovaBiotics, Ltd
    Full Title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (C...
    Medical condition: exacerbation of Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10070608 Infective pulmonary exacerbation of cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001259-29 Sponsor Protocol Number: UoL001306 Start Date*: 2019-03-12
    Sponsor Name:University of LIverpool
    Full Title: A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) IN ADULTS AND CHILDREN WITH HOMOZYGOUS ΔF508 CYSTIC FIBROSIS, IN PATIENTS TAKING EPIGALLOCATECHIN-...
    Medical condition: DeltaF508 Homozygous Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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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