IVACAFTOR 59.5mg ( DrugBank: Ivacaftor )


1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis1

299. Cystic fibrosis


Clinical trials : 1,695 Drugs : 1,527 - (DrugBank : 268) / Drug target genes : 111 - Drug target pathways : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2020-002239-31-DE
(EUCTR)
18/03/202220/12/2021Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Subjects 2 Years and OlderA Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older 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: 80mg ELX / 40mg TEZ / 60mg IVA
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: IVACAFTOR 59.5mg
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 100g ELX / 50mg TEZ / 75mg IVA
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Trade Name: Kalydeco
Product Name: IVACAFTOR 75mg
Product Code: VX-77
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Canada;Australia;Germany;United Kingdom