100g ELX / 50mg TEZ / 75mg IVA ( 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 : 1,695 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
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
2EUCTR2020-002251-38-DE
(EUCTR)
28/09/202120/07/2021Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 YearsA Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age 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
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
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: IVACAFTOR 75mg
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Germany;United Kingdom