A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation
Public ClinicalTrials.gov record NCT03537651. 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, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.
Study identification
- NCT ID
- NCT03537651
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 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
- Apr 25, 2018 (Actual)
- Primary completion
- Oct 28, 2020 (Actual)
- Completion
- Sep 29, 2023 (Actual)
- Last update posted
- Apr 19, 2024
2018 – 2023
United States locations
- U.S. sites
- 28
- U.S. states
- 24
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Providence Alaska Medical Center | Anchorage | Alaska | 99508 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours/ Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Johns Hopkins All Children's Hospital Outpatient Care Center | St. Petersburg | Florida | 33701 | — |
| Center for Advanced Pediatrics | Atlanta | Georgia | 30329 | — |
| St. Luke's CF Center of Idaho | Boise | Idaho | 83702 | — |
| Riley Hospital for Children Indiana University Health | Indianapolis | Indiana | 46202 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Children's Hospital & Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Dartmouth Hitchcock Medical Center | Manchester | New Hampshire | 03756 | — |
| UBMD Pediatrics/ CF Center of Western New York | Buffalo | New York | 14203 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13202 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Sanford Children's Speciality Clinic | Sioux Falls | South Dakota | 57105 | — |
| Austin Children's Chest Associates | Austin | Texas | 78723 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Children's Hospital of Wisconsin | 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 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03537651, 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 Apr 19, 2024 · Synced Oct 17, 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 NCT03537651 live on ClinicalTrials.gov.