A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Public ClinicalTrials.gov record NCT03447249. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
Study identification
- NCT ID
- NCT03447249
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 385 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 6, 2018
- Primary completion
- Feb 4, 2019
- Completion
- Feb 4, 2019
- Last update posted
- Mar 12, 2020
2018 – 2019
United States locations
- U.S. sites
- 48
- U.S. states
- 29
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Hartford Health | Hartford | Connecticut | 06106 | — |
| Yale New Haven Medical Center | New Haven | Connecticut | 06511 | — |
| University of Miami/ Miller School of Medicine | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Arnold Palmer Hospital | Orlando | Florida | 32806 | — |
| Johns Hopkins All Children's Hospital Outpatient Care Center | St. Petersburg | Florida | 33701 | — |
| St. Luke's CF Center of Idaho | Boise | Idaho | 83712 | — |
| Cystic Fibrosis Center of Chicago | Glenview | Illinois | 60025 | — |
| Advocate Children's Hospital - Park Ridge/ North Suburban Pulmonary and Critical Care Consultants | Niles | Illinois | 60714 | — |
| Indiana Clinical Research Center, IU Health University Hospital | Indianapolis | Indiana | 46202 | — |
| The University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Kentucky Clinic | Lexington | Kentucky | 40536 | — |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Helen DeVos Children's Hospital CF Center | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine/ St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| Dartmouth Hitchcock Medical Center, Lebanon | Lebanon | New Hampshire | 03756 | — |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 80901 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| Northwell Health, Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Respiratory Diseases of Children and Adolescents | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center | Philadelphia | Pennsylvania | 19017 | — |
| Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | — |
| Sanford Research/ USD | Sioux Falls | South Dakota | 57105 | — |
| University of Tennessee Medical Center - Adult Cystic Fibrosis Clinic | Knoxville | Tennessee | 37920 | — |
| Children's Foundation Research Center/ Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37920 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah / Primary Children's Medical Center | Salt Lake City | Utah | 84132 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Pediatric Pulmonary & Allergy/Immunology Clinic | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03447249, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 12, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03447249 live on ClinicalTrials.gov.