A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Public ClinicalTrials.gov record NCT04043806. 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 of VX-445 Combination Therapy in Subjects With Cystic Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
Study identification
- NCT ID
- NCT04043806
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 458 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
- Aug 9, 2019 (Actual)
- Primary completion
- Dec 14, 2022 (Actual)
- Completion
- Dec 14, 2022 (Actual)
- Last update posted
- Jul 6, 2023
2019 – 2022
United States locations
- U.S. sites
- 46
- U.S. states
- 29
- U.S. cities
- 45
| 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 Hospital | New Haven | Connecticut | 06510 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Arnold Palmer Hospital Pulmonary and Sleep Medicine | 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 | 83702 | — |
| Cystic Fibrosis Institute | Glenview | Illinois | 60025 | — |
| Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants | Niles | Illinois | 60714 | — |
| Indiana University | 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 | — |
| 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 Medical Center | Lebanon | New Hampshire | 03756 | — |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | — |
| Albany Medical College, Pulmonary and Critical Care Medicine | 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 | — |
| Santiago Reyes, M.D. | Oklahoma City | Oklahoma | 73112 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Sanford Children's Speciality Clinic | Sioux Falls | South Dakota | 57105 | — |
| University of Tennessee Medical Center | 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 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04043806, 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 Jul 6, 2023 · Synced Oct 18, 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 NCT04043806 live on ClinicalTrials.gov.