A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
Public ClinicalTrials.gov record NCT02565914. 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 VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), VX14-661-108 (Study 108, NCT02392234), VX14-661-109 (Study 109, NCT02412111), VX14-661-111 (Study 111, NCT02508207), VX15-661-112 (NCT02730208), and VX16-661-114 (NCT03150719). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.
Study identification
- NCT ID
- NCT02565914
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,131 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 2015 (Actual)
- Primary completion
- May 2019 (Actual)
- Completion
- Dec 5, 2022 (Actual)
- Last update posted
- Sep 28, 2023
2015 – 2022
United States locations
- U.S. sites
- 69
- U.S. states
- 36
- U.S. cities
- 69
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Pensacola | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Glenview | Illinois | — | — |
| Not listed | Niles | Illinois | — | — |
| Not listed | Peoria | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Iowa City | Iowa | — | — |
| Not listed | Lexington | Kentucky | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Detroit | Michigan | — | — |
| 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 | Long Branch | New Jersey | — | — |
| Not listed | New Brunswick | New Jersey | — | — |
| Not listed | Albuquerque | New Mexico | — | — |
| Not listed | Albany | New York | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | New Hyde Park | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Sioux Falls | South Dakota | — | — |
| Not listed | Knoxville | Tennessee | — | — |
| Not listed | Memphis | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Tyler | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Spokane | Washington | — | — |
| Not listed | Morgantown | West Virginia | — | — |
| 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 85 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02565914, 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 28, 2023 · 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 NCT02565914 live on ClinicalTrials.gov.