A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis
Public ClinicalTrials.gov record NCT01931839. 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 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.
The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.
Study identification
- NCT ID
- NCT01931839
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,164 participants
Conditions and interventions
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
- Sep 30, 2013
- Primary completion
- Mar 31, 2016
- Completion
- Mar 31, 2016
- Last update posted
- May 11, 2017
2013 – 2016
United States locations
- U.S. sites
- 91
- U.S. states
- 43
- U.S. cities
- 91
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Anchorage | Alaska | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Loma Linda | California | — | — |
| Not listed | Longbeach | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Madera | California | — | — |
| Not listed | Oakland | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Denver | Colorado | — | — |
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| Not listed | Orlando | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Boise | Idaho | — | — |
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| Not listed | Park Ridge | Illinois | — | — |
| Not listed | Peoria | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Iowa City | Iowa | — | — |
| Not listed | Kansas City | Kansas | — | — |
| Not listed | Lexington | Kentucky | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | South Portland | Maine | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Worcester | Massachusetts | — | — |
| Not listed | Ann Arbor | Michigan | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | Grand Rapids | Michigan | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | Jackson | Mississippi | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Omaha | Nebraska | — | — |
| Not listed | Bedford | New Hampshire | — | — |
| Not listed | Lebanon | New Hampshire | — | — |
| Not listed | Long Branch | New Jersey | — | — |
| Not listed | Morristown | 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 | Lake Success | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | Valhalla | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Dayton | Ohio | — | — |
| Not listed | Toledo | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Portland | Oregon | — | — |
| Not listed | Hershey | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charelston | 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 | San Antonio | Texas | — | — |
| Not listed | Tyler | 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 | Spokane | Washington | — | — |
| Not listed | Morgantown | West Virginia | — | — |
| 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 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01931839, 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 11, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01931839 live on ClinicalTrials.gov.