Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Public ClinicalTrials.gov record NCT02544451. 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, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.
Study identification
- NCT ID
- NCT02544451
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 246 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
- Aug 2015 (Actual)
- Primary completion
- Aug 2018 (Actual)
- Completion
- Apr 2020 (Actual)
- Last update posted
- May 24, 2021
2015 – 2020
United States locations
- U.S. sites
- 37
- U.S. states
- 27
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Wilmington | Delaware | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Iowa City | Iowa | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Dayton | Ohio | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Colchester | Vermont | — | — |
| Not listed | Charlottesville | Virginia | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Richmond | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Madison | Wisconsin | — | — |
| Not listed | Milwaukee | Wisconsin | — | — |
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 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02544451, 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 24, 2021 · 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 NCT02544451 live on ClinicalTrials.gov.