A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
Public ClinicalTrials.gov record NCT03447262. 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.
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Official title
A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.
Study identification
- NCT ID
- NCT03447262
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 484 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
- Jul 13, 2018 (Actual)
- Primary completion
- Sep 9, 2020 (Actual)
- Completion
- Sep 9, 2020 (Actual)
- Last update posted
- Jan 25, 2022
2018 – 2020
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 Hospital | Hartford | Connecticut | 06102 | — |
| 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 | — |
| Orlando Health, Inc.- Arnold Palmer Hospital for Children (APH) | 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 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Michigan Medicine | Ann Arbor | Michigan | 48109-5212 | — |
| Spectrum Health Medical Group Adult Cystic Fibrosis Care Center | Grand Rapids | Michigan | 49546 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine/ St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| Dartmouth Hitchcock, Manchester | Manchester | New Hampshire | 03104 | — |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| CF Therapeutics Development Center of Western New York | Buffalo | New York | 14203 | — |
| 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 | Cincinnati | Ohio | 45229 | — |
| Santiago Reyes, M.D. | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Drexel University College of Medicine / Drexel Adult Cystic Fibrosis Center | Philadelphia | Pennsylvania | 19107 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Sanford Children's Specialty Clinic | 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 | 37232 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Texas Children's Hospital | 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 & Cystic Fibrosis 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 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03447262, 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 Jan 25, 2022 · Synced Nov 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03447262 live on ClinicalTrials.gov.