A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Public ClinicalTrials.gov record NCT03525444. 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-445 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-445 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
- NCT03525444
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 405 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
- Jun 14, 2018
- Primary completion
- Apr 23, 2019
- Completion
- Apr 23, 2019
- Last update posted
- May 18, 2020
2018 – 2019
United States locations
- U.S. sites
- 53
- U.S. states
- 29
- U.S. cities
- 51
| 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/ Children's Hospital of Central California | 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/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital | Hollywood | Florida | 33021 | — |
| Nemours Children's Specialty Care | Jacksonville | Florida | 32207 | — |
| Central Florida Pulmonary Group | Orlando | Florida | 32803 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Tampa General Hospital Cardiac and Lung Transplant Clinic | Tampa | Florida | 33606 | — |
| Children's Speciality 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 | — |
| Saint Francis Medical Center/ Children's Hospital of Illinois/OSF | Peoria | Illinois | 61637 | — |
| 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 | 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 | Billings | Montana | 59101 | — |
| Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| University of New Mexico Clinical & Translational Science Center | Albuquerque | New Mexico | 87131 | — |
| 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 | — |
| University Hospitals Cleveland Medical Center/ Rainbow Babies and Children's Hospital | 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 | — |
| Austin Children's Chest Associates | Austin | Texas | 78723 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | — |
| 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 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03525444, 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 May 18, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03525444 live on ClinicalTrials.gov.