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TEZ/IVA

DRUG13 trials

Sponsors

Vertex Pharmaceuticals Incorporated

Conditions

Cystic Fibrosis

Phase 1

A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
CompletedNCT03227471
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2017-01-23End: 2018-03-27Updated: 2022-01-18
Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis
CompletedNCT03768089
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2018-03-20End: 2019-05-03Updated: 2022-07-14

Phase 2

A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
CompletedNCT02951195
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2016-11-30End: 2018-01-31Updated: 2021-01-28
A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
CompletedNCT03224351
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2017-08-08End: 2018-02-28Updated: 2021-04-22
A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
CompletedNCT03912233
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2019-04-30End: 2019-12-10Updated: 2023-04-20

Phase 3

A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
CompletedNCT02565914
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2015-08-31End: 2022-12-05Updated: 2023-09-28
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
CompletedNCT02953314
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2016-11-30End: 2018-09-30Updated: 2020-03-04
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
CompletedNCT03460990
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2018-05-01End: 2018-10-08Updated: 2019-10-17
A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
CompletedNCT03525548
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2018-08-03End: 2018-12-28Updated: 2020-01-27
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation
CompletedNCT03537651
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2018-04-25End: 2023-09-29Updated: 2024-04-19
A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis
CompletedNCT03559062
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2018-05-17End: 2018-12-21Updated: 2020-02-11
A 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)
CompletedNCT04058353
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2019-08-28End: 2020-06-12Updated: 2021-07-02
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
CompletedNCT04105972
Vertex Pharmaceuticals IncorporatedCystic Fibrosis
Start: 2019-10-03End: 2020-07-24Updated: 2021-08-18

Related Papers

884 Evaluation of the impact of cystic fibrosis modifier therapies on liver function in children and young adults
2023-06-19
Safety and efficacy of vanzacaftor-tezacaftor-deutivacaftor in adults with cystic fibrosis: randomised, double-blind, controlled, phase 2 trials.
2023-02-2342 citations
A Phase 3, open-label, 96-week trial to study the safety, tolerability, and efficacy of tezacaftor/ivacaftor in children ≥ 6 years of age homozygous for F508del or heterozygous for F508del and a residual function CFTR variant.
2022-02-1811 citations
Efficacy and safety of elexacaftor plus tezacaftor plus ivacaftor versus tezacaftor plus ivacaftor in people with cystic fibrosis homozygous for F508del-CFTR: a 24-week, multicentre, randomised, double-blind, active-controlled, phase 3b trial.
2021-12-20108 citations
Triple Therapy for Cystic Fibrosis <i>Phe508del</i> –Gating and –Residual Function Genotypes
New England Journal of Medicine2021-08-25253 citations
Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study.
2021-02-1040 citations
S66 Impact of elexacaftor/tezacaftor/ivacaftor triple combination therapy on health-related quality of life in people with cystic fibrosis homozygous for F508del (F/F): results from a Phase 3 clinical study
2021-01-21
Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial.
2019-10-31957 citations
A phase 3 study of tezacaftor in combination with ivacaftor in children aged 6 through 11 years with cystic fibrosis
Journal of Cystic Fibrosis2019-06-2654 citations
S69 Retrospective analysis of physiological response patterns to tezacaftor/ivacaftor in patients with cystic fibrosis homozygous for F508del-CFTR or heterozygous for f508del-CFTR and a residual function mutation
2018-11-162 citations
VX-445–Tezacaftor–Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles
New England Journal of Medicine2018-10-18707 citations
VX-659–Tezacaftor–Ivacaftor in Patients with Cystic Fibrosis and One or Two Phe508del Alleles
New England Journal of Medicine2018-10-18320 citations