Vx-445/tez/iva    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
299Cystic fibrosis30

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.
30 / 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
1NCT04058210
(ClinicalTrials.gov)
July 21, 202013/8/2019VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR MutationCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLApproved for marketing12 YearsN/AAllNULL
2NCT04183790
(ClinicalTrials.gov)
February 17, 202028/11/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll64Phase 3United States;Australia;Canada;Ireland;United Kingdom
3EUCTR2019-000833-37-DE
(EUCTR)
23/01/202027/06/2019A 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 Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Trikafta
Product Name: 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
4EUCTR2019-000833-37-NL
(EUCTR)
22/01/202017/09/2019A 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 Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
5EUCTR2018-002835-76-NL
(EUCTR)
22/01/202017/09/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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 Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-002835-76-GB
(EUCTR)
29/10/201927/06/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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 Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
7EUCTR2019-000833-37-GB
(EUCTR)
29/10/201927/06/2019A 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 Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
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 finishedFemale: yes
Male: yes
250Phase 3France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
8EUCTR2018-002835-76-IE
(EUCTR)
21/10/201928/06/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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 Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
9EUCTR2018-002835-76-DE
(EUCTR)
21/10/201903/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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 Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
10EUCTR2019-000833-37-DK
(EUCTR)
17/10/201909/07/2019A 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 Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3France;United States;Canada;Belgium;Spain;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-002835-76-DK
(EUCTR)
16/10/201909/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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 Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3France;United States;Canada;Belgium;Spain;Ireland;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom
12EUCTR2018-001695-38-GB
(EUCTR)
09/10/201919/08/2019Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 YearsA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 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: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
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: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
13EUCTR2019-001735-31-GB
(EUCTR)
13/09/201924/06/2019A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic FibrosisA Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: ELEXACAFTOR
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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;Australia;Germany;United Kingdom
14EUCTR2019-000833-37-FR
(EUCTR)
02/09/201912/07/2019A 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 Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
15NCT03691779
(ClinicalTrials.gov)
October 2, 201828/9/2018Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of AgeA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of AgeCystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll66Phase 3United States;Australia;Ireland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-000183-28-CZ
(EUCTR)
01/10/201809/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
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 VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
17EUCTR2018-000183-28-GB
(EUCTR)
27/09/201804/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
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 VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
18EUCTR2018-000184-89-GB
(EUCTR)
27/09/201804/07/2018A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
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: 100mg VX-445/50mg TEZ /75mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Product Name: 100 mg TEZ/150 mg IVA FDC
Product Code: TEZ/IVA
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Belgium;Netherlands;United Kingdom
19EUCTR2018-000183-28-NL
(EUCTR)
03/09/201818/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
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 VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
20EUCTR2018-000183-28-SE
(EUCTR)
27/08/201829/06/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
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 VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-000183-28-AT
(EUCTR)
24/08/201820/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
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 VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
22NCT03525548
(ClinicalTrials.gov)
August 3, 20182/5/2018A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)Cystic FibrosisDrug: VX-445/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll113Phase 3United States;Belgium;Netherlands;United Kingdom
23NCT03525444
(ClinicalTrials.gov)
June 15, 20182/5/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: VX-445/TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll405Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom
24EUCTR2018-002835-76-BE
(EUCTR)
25/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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 Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
25EUCTR2018-000185-11-DE
(EUCTR)
03/07/2018A 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]
Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
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
Trade Name: Trikafta
Product Name: 100-mg ELX (VX-445) / 50-mg TEZ / 75-mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-c
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-001827-11-GB
(EUCTR)
11/12/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age 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]
Vertex Pharmaceuticals IncorporatedNULLNA Female: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
27EUCTR2018-002835-76-FR
(EUCTR)
12/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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 Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
250Phase 3United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
28EUCTR2019-001735-31-BE
(EUCTR)
08/07/2019A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic FibrosisA Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto 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 VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: ELEXACAFTOR
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: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
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;Australia;Germany;United Kingdom
29EUCTR2018-001695-38-IE
(EUCTR)
28/08/2019Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 YearsA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 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: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
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: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
30EUCTR2019-001827-11-IE
(EUCTR)
20/12/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age 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: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
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: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom