A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)
Public ClinicalTrials.gov record NCT03150719. 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
Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).
Study identification
- NCT ID
- NCT03150719
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 98 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
- May 24, 2017 (Actual)
- Primary completion
- Aug 9, 2018 (Actual)
- Completion
- Aug 9, 2018 (Actual)
- Last update posted
- Sep 12, 2019
2017 – 2018
United States locations
- U.S. sites
- 41
- U.S. states
- 28
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| UCSF - Fresno, Community Regional Medical Center | Fresno | California | 93701 | — |
| Miller Children's Hospital / Long Beach Memorial | Long Beach | California | 90806 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Rady Children's Hospital | San Diego | California | 92123 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Central Florida Pulmonary Group | Orlando | Florida | 32803 | — |
| Arnold Palmer Hospital | Orlando | Florida | 32806 | — |
| Tampa General Hospital Cardiac and Lung Transplant Clinic | Tampa | Florida | 33606 | — |
| Children's Speciality Services at North Druid Hills | Atlanta | Georgia | 30324 | — |
| St. Luke's CF Center of Idaho | Boise | Idaho | 83702 | — |
| Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants | Niles | Illinois | 60714 | — |
| Southern Illinois University | Springfield | Illinois | 62702 | — |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | 46202 | — |
| The University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Kentucky Clinic | Lexington | Kentucky | 40536 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Massachusetts General Hospital Cystic Fibrosis Center | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Santiago Reyes, M.D. | Oklahoma City | Oklahoma | 73112 | — |
| Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center | Philadelphia | Pennsylvania | 19107 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| The University of Tennessee Medical Center | Nashville | Tennessee | 37920 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | — |
| University of Utah / Primary Children's Medical Center | Salt Lake City | Utah | 84132 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
| Children's Hospital of Richmond at VCU, Children's Pavilion | Richmond | Virginia | 23298 | — |
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 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03150719, 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 12, 2019 · 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 NCT03150719 live on ClinicalTrials.gov.