A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
Public ClinicalTrials.gov record NCT02953314. 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 VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation
Study identification
- NCT ID
- NCT02953314
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Industry
- Enrollment
- 83 participants
Conditions and interventions
Conditions
Interventions
- TEZ Drug
- TEZ/IVA Drug
- IVA 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
- Oct 31, 2016
- Primary completion
- Aug 31, 2018
- Completion
- Aug 31, 2018
- Last update posted
- Mar 3, 2020
2016 – 2018
United States locations
- U.S. sites
- 30
- U.S. states
- 24
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Anchorage | Alaska | — | — |
| Not listed | Little Rock | Arkansas | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Wilmington | Delaware | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | St. Petersburg | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Boise | Idaho | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Manchester | New Hampshire | — | — |
| Not listed | Buffalo | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Syracuse | New York | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Cleveland | Ohio | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Charleston | South Carolina | — | — |
| Not listed | Sioux Falls | South Dakota | — | — |
| Not listed | Austin | Texas | — | — |
| Not listed | Fort Worth | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| 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 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02953314, 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 Mar 3, 2020 · Synced Jun 26, 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 protocol, eligibility criteria, and contact information for NCT02953314 live on ClinicalTrials.gov.