Ivacaftor 150 mg ( DrugBank: Ivacaftor )


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3

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
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size
PhaseCountries
1NCT05599230
(ClinicalTrials.gov)
September 1, 202221/10/2022Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.Cystic FibrosisDrug: Elexacaftor 100 MG / Ivacaftor 75 MG / Tezacaftor 50 MG, 2 tablets each morning + Ivacaftor 150 mg one tablet each eveningCHC MontlegiaNULLActive, not recruiting12 YearsN/AAll20Belgium
2NCT00457821
(ClinicalTrials.gov)
May 20075/4/2007Safety Study of Ivacaftor in Subjects With Cystic FibrosisA Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551DCystic FibrosisDrug: Ivacaftor 25 mg/75 mg;Drug: Ivacaftor 75 mg/150 mg;Drug: Ivacaftor 150 mg or 250 mg;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted18 YearsN/AAll39Phase 2United States;Canada;Germany
3EUCTR2017-002968-40-DE
(EUCTR)
05/04/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation 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: Symdeko
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symdeko
Product Name: Ivacaftor 75 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor 150 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland