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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Lumacaftor Plus Ivacaftor Combination Clear all
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 19, 2017 · Synced Sep 17, 2026, 3:28 AM 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 29, 2018 · Synced Sep 17, 2026, 3:28 AM 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 30, 2015 · Synced Sep 17, 2026, 3:28 AM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

NCT01931839
View directory record Official record
Conditions
Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Interventions
Lumacaftor Plus Ivacaftor Combination, Ivacaftor
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Years and older
Enrollment
1,164 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
91
States / cities
Birmingham, Alabama • Anchorage, Alaska • Tucson, Arizona + 88 more
Source: ClinicalTrials.gov public record
Updated May 11, 2017 · Synced Sep 17, 2026, 3:28 AM 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 22, 2017 · Synced Sep 17, 2026, 3:28 AM 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 26, 2016 · Synced Sep 17, 2026, 3:28 AM 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 4, 2015 · Synced Sep 17, 2026, 3:28 AM 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 23, 2021 · Synced Sep 17, 2026, 3:28 AM 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 28, 2021 · Synced Sep 17, 2026, 3:28 AM EDT
Completed Phase 3 Interventional Results available

Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

NCT04235140
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
LUM/IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Months and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
20
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Aurora, Colorado + 17 more
Source: ClinicalTrials.gov public record
Updated Sep 18, 2024 · Synced Sep 17, 2026, 3:28 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

NCT03140527
View directory record Official record
Conditions
Healthy Volunteer, Cystic Fibrosis
Interventions
PTI-801, Placebo, PTI-808
Drug
Lead sponsor
Proteostasis Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
171 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2020
U.S. locations
33
States / cities
Birmingham, Alabama • Anchorage, Alaska • Stanford, California + 28 more
Source: ClinicalTrials.gov public record
Updated Apr 29, 2020 · Synced Sep 17, 2026, 3:28 AM EDT
Completed Phase 3 Interventional Results available

Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del

NCT03601637
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
LUM, IVA
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
12 Months to 23 Months
Enrollment
61 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
24
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Palo Alto, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jan 5, 2023 · Synced Sep 17, 2026, 3:28 AM 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 5, 2017 · Synced Sep 17, 2026, 3:28 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

NCT01899105
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
lumacaftor, ivacaftor
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
18 Years to 55 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013
U.S. locations
1
States / cities
Daytona Beach, Florida
Source: ClinicalTrials.gov public record
Updated Apr 2, 2014 · Synced Sep 17, 2026, 3:28 AM EDT
Recruiting Early Phase 1 Interventional

Personalized Theratyping Trial

NCT03587961
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Symdeko
Drug
Lead sponsor
George Solomon
Other
Eligibility
6 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2027
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Feb 1, 2026 · Synced Sep 17, 2026, 3:28 AM EDT
Completed No phase listed Observational

Orkambi Treatment in 2 to 5 Year Old Children With CF

NCT03795363
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Orkambi
Drug
Lead sponsor
Children's Hospital of Philadelphia
Other
Eligibility
2 Years to 5 Years
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Dec 1, 2021 · Synced Sep 17, 2026, 3:28 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

NCT01768663
View directory record Official record
Conditions
Cystic Fibrosis
Interventions
Lumacaftor, Ivacaftor, Ciprofloxacin, Itraconazole, Rifampin
Drug
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Eligibility
18 Years to 55 Years
Enrollment
80 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
Started 2013
U.S. locations
1
States / cities
Evansville, Indiana
Source: ClinicalTrials.gov public record
Updated Nov 14, 2013 · Synced Sep 17, 2026, 3:28 AM 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 11, 2019 · Synced Sep 17, 2026, 3:28 AM 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 6, 2020 · Synced Sep 17, 2026, 3:28 AM EDT