299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174

  
7 trials found
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1EUCTR2017-001259-29-GB
(EUCTR)
12/03/201921/12/2018A study to establish the tolerabilty and adverse effects in people with a severe form of Cystic Fibrosi (delta F 508 homozygous) when using a combination of two products - cyteamine (a licensed medicine being used in a new disease) and EGCG (a food supplement).A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) IN ADULTS AND CHILDREN WITH HOMOZYGOUS ?F508 CYSTIC FIBROSIS, IN PATIENTS TAKING EPIGALLOCATECHIN-3-GALLATE (EGCG, EPINERVE) FOOD SUPPLEMENTATION - Delta Dose Study DeltaF508 Homozygous Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cystagon
Product Name: Cystagon
INN or Proposed INN: cysteamine bitartrate
Other descriptive name: 2-aminoethanethiol;2,3-dihydroxybutanedioic acid
University of LIverpoolNULLNot RecruitingFemale: yes
Male: yes
44Phase 1;Phase 2United Kingdom
2EUCTR2015-004986-99-IT
(EUCTR)
11/01/201706/09/2016A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.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 (CF) Being Treated for an Exacerbation of CF-associated Lung Disease. exacerbation of Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: cysteamine bitartrateNovaBiotics, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Netherlands;United Kingdom;Italy
3NCT03000348
(ClinicalTrials.gov)
December 201611/12/2016A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis ExacerbationsA Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung DiseaseCystic FibrosisDrug: Cysteamine;Drug: Placebo Oral CapsuleNovaBiotics Ltd.Agility Clinical, Inc.;PSR Group B.V.Completed18 YearsN/AAll91Phase 2United States;Italy;United Kingdom
4EUCTR2015-004986-99-GB
(EUCTR)
31/10/201606/09/2016A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease.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 (CF) Being Treated for an Exacerbation of CF-associated Lung Disease. exacerbation of Cystic Fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: cysteamine bitartrateNovaBiotics, LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Netherlands;Italy;United Kingdom
5NCT02212431
(ClinicalTrials.gov)
August 20147/8/2014First Study of Oral Cysteamine in Cystic FibrosisAn Open Label Investigation of the Tolerability and Pharmacokinetics of Oral Cysteamine in Adults With Cystic Fibrosis.Cystic FibrosisDrug: CysteamineUniversity of AberdeenCystic Fibrosis Trust;NHS Grampian;University of Huddersfield;Cystic Fibrosis Trust;NHS Grampian;University of HuddersfieldCompleted18 YearsN/ABoth10Phase 1/Phase 2United Kingdom
6EUCTR2014-000284-40-GB
(EUCTR)
05/06/201429/04/2014Cysteamine in Cystic FibrosisAn open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis. - Cysteamine in Cystic Fibrosis (2) Cystic Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cystagon (cysteamine bitartrate) immediate-release capsules
Product Name: Cystagon (cysteamine bitartrate) immediate-release capsules
INN or Proposed INN: cysteamine bitartrate
University of AberdeenNHS GrampianNot RecruitingFemale: yes
Male: yes
12Phase 1;Phase 2United Kingdom
7EUCTR2013-001258-82-IT
(EUCTR)
12/09/201329/07/2013Phase II clinical study for the therapy of cystic fibrosis patients with aspecific mutationA phase II pilot clinical study of experimental research to evaluate thefunctional rescue of CFTR protein through proteostasis regulators - Proteostasis regulators effect in cystic fibrosis therapy Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II mutations;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]Trade Name: Cystagon
Product Name: Cysteamine bitartrate (Cystagon)
Product Code: EMEA/H/C/000125
European Institute for Cystic Fibrosis Research (IERFC)NULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy