VX-371 in hypertonic saline ( 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4

299. 嚢胞性線維症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-004841-13-CZ
(EUCTR)
04/01/201710/08/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi 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]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
2EUCTR2015-004841-13-IE
(EUCTR)
08/08/201607/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi 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]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic Saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
3EUCTR2015-004841-13-GB
(EUCTR)
20/07/201609/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi 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]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Ireland;United Kingdom
4EUCTR2015-004841-13-FR
(EUCTR)
23/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi 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: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Czech Republic;Ireland;United Kingdom