100 mg elx/50 mg tez /75 mg iva fdc    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis4

299. Cystic fibrosis    [ 1,592 clinical trials,   1,539 drugs,   (DrugBank: 255 drugs),   81 drug target genes,   162 drug target pathways]
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.
4 / 1,592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000185-11-AT
(EUCTR)
27/02/201919/10/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del 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: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
2EUCTR2018-000185-11-GR
(EUCTR)
20/12/201828/11/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del 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: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
3EUCTR2018-000185-11-NL
(EUCTR)
14/11/201819/09/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del 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: Trifakta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
4EUCTR2018-000185-11-GB
(EUCTR)
19/10/201804/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del 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: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden