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ClinicalTrials.gov public records Last synced Oct 8, 2026, 5:51 PM EDT

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Showing 1–24 of 26 matching trials from the live ClinicalTrials.gov search.
Filters: Condition: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Clear all
Completed Phase 2 Interventional

Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation

NCT02589236
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Cavosonstat, Placebo
Drug
Lead sponsor
Nivalis Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
138 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
46
States / cities
Birmingham, Alabama • Tucson, Arizona • Los Angeles, California + 42 more
Source: ClinicalTrials.gov public record
Updated Jan 10, 2017 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation

NCT05076149
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
VX-121/TEZ/D-IVA, ELX/TEZ/IVA, IVA, Placebo (matched to VX-121/TEZ/D-IVA), Placebo (matched to ELX/TEZ/IVA), Placebo (matched to IVA)
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
597 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
62
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 55 more
Source: ClinicalTrials.gov public record
Updated Jun 13, 2024 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

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

NCT02565914
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
TEZ/IVA, IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
1,131 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2022
U.S. locations
69
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 66 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2023 · Synced Oct 8, 2026, 5:51 PM EDT
Terminated Phase 2 Interventional Results available

Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation

NCT00953706
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Ivacaftor, Placebo
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
140 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
34
States / cities
Birmingham, Alabama • Anchorage, Alaska • Oakland, California + 30 more
Source: ClinicalTrials.gov public record
Updated Sep 11, 2015 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

NCT01807923
View directory record Official record
Conditions
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Interventions
Lumacaftor Plus Ivacaftor Combination, Ivacaftor, Placebo
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
559 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
48
States / cities
Birmingham, Alabama • Anchorage, Alaska • Tucson, Arizona + 45 more
Source: ClinicalTrials.gov public record
Updated Aug 31, 2015 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

NCT02070744
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
VX-661, Ivacaftor, Placebo matched to VX-661, Placebo matched to Ivacaftor
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
23
States / cities
Birmingham, Alabama • Palo Alto, California • Stanford, California + 20 more
Source: ClinicalTrials.gov public record
Updated Sep 24, 2025 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 1 Interventional Results available

Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation

NCT01746784
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
N6022, Normal saline
Drug
Lead sponsor
Nivalis Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014
U.S. locations
17
States / cities
Birmingham, Alabama • Anchorage, Alaska • Palo Alto, California + 14 more
Source: ClinicalTrials.gov public record
Updated Nov 24, 2014 · Synced Oct 8, 2026, 5:51 PM EDT
Terminated Phase 4 Interventional Results available

A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation

NCT02823470
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
LUM/IVA, activated smart device, de-activated smart device
Drug · Device
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
16 Years and older
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
7
States / cities
Hartford, Connecticut • Washington D.C., District of Columbia • Orlando, Florida + 4 more
Source: ClinicalTrials.gov public record
Updated Sep 27, 2018 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

NCT01807949
View directory record Official record
Conditions
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Interventions
Placebo, Lumacaftor Plus Ivacaftor Combination, Ivacaftor
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years to 65 Years
Enrollment
563 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
46
States / cities
Oakland, California • Sacramento, California • Aurora, Colorado + 43 more
Source: ClinicalTrials.gov public record
Updated Sep 27, 2016 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)

NCT02953314
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
TEZ, TEZ/IVA, IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
6 Years to 11 Years
Enrollment
83 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
30
States / cities
Birmingham, Alabama • Anchorage, Alaska • Little Rock, Arkansas + 27 more
Source: ClinicalTrials.gov public record
Updated Mar 4, 2020 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

NCT02544451
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
LUM/IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
6 Years and older
Enrollment
246 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
37
States / cities
Birmingham, Alabama • Tucson, Arizona • Long Beach, California + 34 more
Source: ClinicalTrials.gov public record
Updated May 24, 2021 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del

NCT02797132
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
LUM/IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
2 Years to 5 Years
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
17
States / cities
Palo Alto, California • Aurora, Colorado • Chicago, Illinois + 14 more
Source: ClinicalTrials.gov public record
Updated Oct 30, 2018 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation

NCT03537651
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
TEZ/IVA, IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
6 Years and older
Enrollment
130 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
28
States / cities
Birmingham, Alabama • Anchorage, Alaska • Little Rock, Arkansas + 25 more
Source: ClinicalTrials.gov public record
Updated Apr 19, 2024 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

NCT03125395
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
LUM/IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
2 Years and older
Enrollment
57 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
17
States / cities
Palo Alto, California • Aurora, Colorado • Chicago, Illinois + 14 more
Source: ClinicalTrials.gov public record
Updated Aug 7, 2020 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease

NCT02390219
View directory record Official record
Conditions
Cystic Fibrosis, Advanced Lung Disease
Interventions
Lumacaftor, Ivacaftor
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
6
States / cities
Denver, Colorado • Tampa, Florida • Chicago, Illinois + 3 more
Source: ClinicalTrials.gov public record
Updated Dec 6, 2017 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 2 Interventional Results available

Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation

NCT01225211
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Lumacaftor, Ivacaftor, Lumacaftor Placebo, Ivacaftor Placebo
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
18 Years and older
Enrollment
312 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
38
States / cities
Birmingham, Alabama • Anchorage, Alaska • La Jolla, California + 35 more
Source: ClinicalTrials.gov public record
Updated Oct 5, 2015 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 2 Interventional Results available

A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

NCT02508207
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Tezacaftor/Ivacaftor, Ivacaftor, Tezacaftor/Ivacaftor matching placebo, Ivacaftor matching placebo
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
18 Years and older
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
7
States / cities
Birmingham, Alabama • Indianapolis, Indiana • Baltimore, Maryland + 4 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2021 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

NCT01897233
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Lumacaftor, Ivacaftor
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
6 Years to 11 Years
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
19
States / cities
Birmingham, Alabama • Tucson, Arizona • Long Beach, California + 16 more
Source: ClinicalTrials.gov public record
Updated Jun 20, 2017 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 1 Interventional

Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation

NCT02275936
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
N91115
Drug
Lead sponsor
Nivalis Therapeutics, Inc.
Industry
Eligibility
18 Years to 80 Years
Enrollment
51 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015
U.S. locations
19
States / cities
Birmingham, Alabama • Palo Alto, California • Aurora, Colorado + 15 more
Source: ClinicalTrials.gov public record
Updated Nov 7, 2016 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

NCT02347657
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
VX-661 Plus Ivacaftor Combination, Ivacaftor, VX-661 Plus Ivacaftor Combination Placebo, Ivacaftor placebo
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
510 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
27
States / cities
Little Rock, Arkansas • Long Beach, California • Denver, Colorado + 24 more
Source: ClinicalTrials.gov public record
Updated Jun 12, 2018 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 2 Interventional Results available

A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation

NCT02709109
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
VX-371 + HS, Hypertonic saline, Placebo, Orkambi, VX-371
Drug
Lead sponsor
Parion Sciences
Industry
Eligibility
12 Years and older
Enrollment
147 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
30
States / cities
Little Rock, Arkansas • Oakland, California • Gainesville, Florida + 27 more
Source: ClinicalTrials.gov public record
Updated Jul 29, 2021 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)

NCT03150719
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Tezacaftor/Ivacaftor, Ivacaftor, Placebo
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
98 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
41
States / cities
Birmingham, Alabama • Phoenix, Arizona • Fresno, California + 34 more
Source: ClinicalTrials.gov public record
Updated Sep 12, 2019 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 2 Interventional Results available

Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation

NCT01531673
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
VX-661, Ivacaftor, Placebo matched to VX-661, Placebo matched to ivacaftor
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
194 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
19
States / cities
Birmingham, Alabama • Oakland, California • Boise, Idaho + 16 more
Source: ClinicalTrials.gov public record
Updated Apr 13, 2018 · Synced Oct 8, 2026, 5:51 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation

NCT02514473
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
VX-809, Placebo, VX-770
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
6 Years to 11 Years
Enrollment
206 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
29
States / cities
Birmingham, Alabama • Los Angeles, California • Palo Alto, California + 26 more
Source: ClinicalTrials.gov public record
Updated Oct 23, 2017 · Synced Oct 8, 2026, 5:51 PM EDT