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Clinical trials for Cysteamine

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   44363   clinical trials with a EudraCT protocol, of which   7387   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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    15 result(s) found for: Cysteamine. 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: 2010-020098-18 Sponsor Protocol Number: 2010-605 Start Date*: 2010-09-09
    Sponsor Name:HOSPICES CIVILS DE LYON
    Full Title: CrYSTobs A cohort of patients with cystinosis : compliance to cysteamine and neurological complications An auxiliary study to Raptor RP103 03 and RP103 04
    Medical condition: nephropatic cystinosis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10011777 Cystinosis LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003228-35 Sponsor Protocol Number: 18072013 Start Date*: 2014-07-16
    Sponsor Name:Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    Full Title: Study of the preliminary efficacy and safety of topical cysteamine formulated in viscous solution in cystinosis patients
    Medical condition: Cystinosis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10011777 Cystinosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    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
    EudraCT Number: 2022-001819-12 Sponsor Protocol Number: CIS-COV Start Date*: 2022-10-13
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Cysteamine in association with standard therapy for the treatment of hospitalized patients with COVID-19 pneumonia: phase 2 study on safety of a new antiviral and direct therapy on the host
    Medical condition: Covid-19 infection
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004862 10084401 COVID-19 respiratory infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    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: 2019-002514-40 Sponsor Protocol Number: CISTA-TB Start Date*: 2019-10-31
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Phase II study on the safety and efficacy of cysteamine in association with standard tuberculosis therapy for the treatment of patients with pulmonary tuberculosis: a new therapy for tuberculosis d...
    Medical condition: Pulmonary Mycobacterium tuberculosis infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10037440 Pulmonary tuberculosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-002773-64 Sponsor Protocol Number: RP103-07 Start Date*: 2014-01-22
    Sponsor Name:Horizon Pharma USA, Inc.
    Full Title: A Long-Term Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Cystinosis
    Medical condition: Cystinosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011777 Cystinosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) NL (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2007-006024-35 Sponsor Protocol Number: cysteamine gel formulation/07/cysta Start Date*: 2008-02-04
    Sponsor Name:Orphan Europe SARL
    Full Title: Adaptive dose regimen of Cystadrops for cOrneal Crystal deposiTs and ocular manifestations in nephropathic cystinosis : an open label, dose-response pilot study
    Medical condition: Nephropathic cystinotic patients with cystine crystals corneal deposits
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-017882-42 Sponsor Protocol Number: RP103-03 Start Date*: 2010-08-12
    Sponsor Name:Raptor Therapeutics Inc.
    Full Title: A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients ...
    Medical condition: Cystinosis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10011777 Cystinosis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2010-018365-34 Sponsor Protocol Number: RP103-04 Start Date*: Information not available in EudraCT
    Sponsor Name:Raptor Therapeutics Inc.
    Full Title: A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients with Nephropathic Cystinosis
    Medical condition: Cystinosis
    Disease: Version SOC Term Classification Code Term Level
    12.1 10011777 Cystinosis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-012564-13 Sponsor Protocol Number: Cystadrops®/09/choc-study Start Date*: 2013-01-03
    Sponsor Name:Orphan Europe SARL
    Full Title: Cysteamine Hydrochloride for nephropathic Cystinosis, open-label Phase III pivotal study
    Medical condition: Nephropatic cystinosis patients with cystine corneal deposits
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004850 10071112 Nephropathic cystinosis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-019444-39 Sponsor Protocol Number: PHRC2004-03bis Start Date*: 2010-06-18
    Sponsor Name:Centre Hospitalier Universitaire d'Angers
    Full Title: Essai multicentrique de traitement de la maladie de Huntington par la cystéamine
    Medical condition: Maladie de Huntington.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10020469 Huntington's chorea LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-002984-24 Sponsor Protocol Number: CYT-C2-001 Start Date*: 2019-10-25
    Sponsor Name:RECORDATI Rare Diseases SARL
    Full Title: Open-label, Single-arm, Multicenter Study to Assess the Safety of Cystadrops® in Pediatric Cystinosis Patients from 6 Months to Less Than 2 Years Old [SCOB2 Study]
    Medical condition: Corneal cystine crystal deposits in pediatric patients with nephropathic cystinosis from 6 months to less than 2 years old
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Ongoing) DE (Ongoing) BE (Completed) IT (Completed)
    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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