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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-001259-29-GB (EUCTR) | 12/03/2019 | 21/12/2018 | A 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 LIverpool | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 1;Phase 2 | United Kingdom | ||
| 2 | EUCTR2015-004986-99-IT (EUCTR) | 11/01/2017 | 06/09/2016 | A 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 bitartrate | NovaBiotics, Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Netherlands;United Kingdom;Italy | ||
| 3 | NCT03000348 (ClinicalTrials.gov) | December 2016 | 11/12/2016 | A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations | A 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 Disease | Cystic Fibrosis | Drug: Cysteamine;Drug: Placebo Oral Capsule | NovaBiotics Ltd. | Agility Clinical, Inc.;PSR Group B.V. | Completed | 18 Years | N/A | All | 91 | Phase 2 | United States;Italy;United Kingdom |
| 4 | EUCTR2015-004986-99-GB (EUCTR) | 31/10/2016 | 06/09/2016 | A 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 bitartrate | NovaBiotics, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Netherlands;Italy;United Kingdom | ||
| 5 | NCT02212431 (ClinicalTrials.gov) | August 2014 | 7/8/2014 | First Study of Oral Cysteamine in Cystic Fibrosis | An Open Label Investigation of the Tolerability and Pharmacokinetics of Oral Cysteamine in Adults With Cystic Fibrosis. | Cystic Fibrosis | Drug: Cysteamine | University of Aberdeen | Cystic Fibrosis Trust;NHS Grampian;University of Huddersfield;Cystic Fibrosis Trust;NHS Grampian;University of Huddersfield | Completed | 18 Years | N/A | Both | 10 | Phase 1/Phase 2 | United Kingdom |
| 6 | EUCTR2014-000284-40-GB (EUCTR) | 05/06/2014 | 29/04/2014 | Cysteamine in Cystic Fibrosis | An 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 Aberdeen | NHS Grampian | Not Recruiting | Female: yes Male: yes | 12 | Phase 1;Phase 2 | United Kingdom | ||
| 7 | EUCTR2013-001258-82-IT (EUCTR) | 12/09/2013 | 29/07/2013 | Phase II clinical study for the therapy of cystic fibrosis patients with aspecific mutation | A 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) | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy |