Lum/iva fixed-dose combination    (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2

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 1,592 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2017-003761-99-DE
(EUCTR)
27/06/201819/02/2018A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del 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 Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Orkambi 100 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Germany
2EUCTR2016-001585-29-NL
(EUCTR)
21/12/201618/07/2016Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-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: Orkambi 200 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Netherlands