G957389 (DrugBank: -)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 299 | 嚢胞性線維症 | 7 |
| 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 | EUCTR2016-004477-40-ES (EUCTR) | 31/05/2017 | 10/03/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;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: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 2 | EUCTR2016-004477-40-BE (EUCTR) | 08/05/2017 | 21/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;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: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Spain;Belgium;Netherlands;United Kingdom | ||
| 3 | EUCTR2016-004477-40-NL (EUCTR) | 10/04/2017 | 14/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;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: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 4 | EUCTR2016-002837-31-CZ (EUCTR) | 04/01/2017 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis 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: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 5 | EUCTR2016-002837-31-DE (EUCTR) | 29/12/2016 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross | Cystic Fibrosis 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: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 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 |
| 6 | EUCTR2016-002837-31-BE (EUCTR) | 16/12/2016 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis 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: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 7 | EUCTR2016-002837-31-IE (EUCTR) | 02/12/2016 | 04/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis 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: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom |