Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Public ClinicalTrials.gov record NCT01897233. 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 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Study identification
- NCT ID
- NCT01897233
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Industry
- Enrollment
- 62 participants
Conditions and interventions
Conditions
Interventions
- Lumacaftor Drug
- Ivacaftor Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years to 11 Years
- 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
- Jun 30, 2013
- Primary completion
- Sep 30, 2015
- Completion
- Sep 30, 2015
- Last update posted
- Jun 19, 2017
2013 – 2015
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 19
| 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 | Atlanta | Georgia | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
| 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01897233, 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 Jun 19, 2017 · Synced Jun 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01897233 live on ClinicalTrials.gov.