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 | EUCTR2015-003291-77-DE (EUCTR) | 25/05/2016 | 11/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 2 | EUCTR2015-003292-30-NL (EUCTR) | 26/02/2016 | 02/12/2015 | A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation | A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. | Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Belgium;Netherlands | ||
| 3 | EUCTR2015-003291-77-IE (EUCTR) | 03/02/2016 | 03/12/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 4 | EUCTR2015-003291-77-GB (EUCTR) | 02/02/2016 | 03/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 5 | NCT02707562 (ClinicalTrials.gov) | February 2016 | 22/2/2016 | Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation) | A Phase IIa, Open-label Study of Multiple Doses of GLPG1837 in Subjects With Cystic Fibrosis and the G551D Mutation | Cystic Fibrosis | Drug: GLPG1837 dose 1;Drug: GLPG1837 dose 2;Drug: GLPG1837 dose 3 | Galapagos NV | NULL | Completed | 18 Years | N/A | Both | 26 | Phase 2 | Australia;Czech Republic;Germany;Ireland;United Kingdom |
| 6 | EUCTR2015-003291-77-CZ (EUCTR) | 26/01/2016 | 16/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 7 | EUCTR2015-003292-30-BE (EUCTR) | 18/01/2016 | 26/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation | A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. | Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Belgium;Netherlands | ||
| 8 | NCT02690519 (ClinicalTrials.gov) | January 2016 | 16/2/2016 | Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation) | A Phase IIa, Open-label Study of Two Doses of GLPG1837 in Subjects With Cystic Fibrosis and the S1251N Mutation | Cystic Fibrosis | Drug: GLPG1837 dose 1;Drug: GLPG1837 dose 2 | Galapagos NV | NULL | Completed | 18 Years | N/A | Both | 7 | Phase 2 | Belgium;Netherlands |