A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Public ClinicalTrials.gov record NCT03525574. 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, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 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.
The study evaluates the long-term safety and tolerability of VX-445 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
- NCT03525574
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 507 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
- Oct 9, 2018 (Actual)
- Primary completion
- Jan 9, 2023 (Actual)
- Completion
- Jan 9, 2023 (Actual)
- Last update posted
- Sep 24, 2025
2018 – 2023
United States locations
- U.S. sites
- 52
- U.S. states
- 29
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Miller Children's Hospital / Long Beach Memorial | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Valley Children's Hospital | Madera | California | 93636 | — |
| Kaiser Permanente | Oakland | California | 94611 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| UCSF Gateway Medical Center | San Francisco | California | 94143 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| University of Florida, Shands Hospital | Gainesville | Florida | 32610 | — |
| Joe DiMaggio Cystic Fibrosis & Pulmonary Center | Hollywood | Florida | 33021 | — |
| Nemours Children's Specialty Care | Jacksonville | Florida | 32207 | — |
| Central Florida Pulmonary Group, PA | Orlando | Florida | 32803 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Tampa General Hospital Cardiac and Lung Transplant Clinic | Tampa | Florida | 33606 | — |
| Children's Specialty Services at North Druid Hills | Atlanta | Georgia | 30324 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Ann & Robert Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Maine Medical Partners | Portland | Maine | 04102 | — |
| Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center | Boston | Massachusetts | 02114 | — |
| Harper University Hospital | Detroit | Michigan | 48201 | — |
| Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| Billings Clinic Hospital | Billings | Montana | 59101 | — |
| Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| UNM Clinical and Translational Science Center | Albuquerque | New Mexico | 87131 | — |
| The Cystic Fibrosis Center, Mount Sinai Beth Israel | New York | New York | 10003 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| UNC Marsico Clinical Research Center | Chapel Hill | North Carolina | 27517 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| UC Health Holmes | Cincinnati | Ohio | 45220 | — |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | — |
| ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Vermont Lung Center | Colchester | Vermont | 05446 | — |
| University of Virginia Primary Care Center | Charlottesville | Virginia | 22908 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
| Children's Hospital of Richmond at VCU, Children's Pavilion | Richmond | Virginia | 23298 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| University of Wisconsin Hospitals and Clinics | Madison | Wisconsin | 53792 | — |
| CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | 53226 | — |
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 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03525574, 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 Sep 24, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03525574 live on ClinicalTrials.gov.