100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC ( 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
Target_
size
PhaseCountries
1EUCTR2019-003455-11-DE
(EUCTR)
08/04/202009/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects 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: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: Ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
2EUCTR2019-003455-11-GB
(EUCTR)
17/01/202009/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects 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: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
158 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Australia;Germany;United Kingdom
3EUCTR2019-003455-11-BE
(EUCTR)
23/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects 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: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;United Kingdom;Australia;Germany