Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation
Public ClinicalTrials.gov record NCT00909727. 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, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.
Study identification
- NCT ID
- NCT00909727
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 52 participants
Conditions and interventions
Conditions
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
- Aug 2009 (Type not available)
- Primary completion
- Nov 2010 (Actual)
- Completion
- Apr 2011 (Actual)
- Last update posted
- Aug 21, 2012
2009 – 2011
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233-1711 | — |
| Emory Cystic Fibrosis Center | Atlanta | Georgia | 30322 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| The Cystic Fibrosis Center of Chicago | Glenview | Illinois | 60025 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Iowa Department of Pediatrics | Iowa City | Iowa | 52242 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| Helen DeVos Children's Hospital Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| University of Nebraska Medical Center Pediatric Pulmonary/ CF | Omaha | Nebraska | 68195-5190 | — |
| East Tennessee Children's Hospital Pediatric Pulmonary and Respiratory Care | Knoxville | Tennessee | 37916 | — |
| University of Utah Pediatric Pulmonology | Salt Lake City | Utah | 84108 | — |
| University of Virginia Pediatric Respiratory Medicine | Charlottesville | Virginia | 22908 | — |
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 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00909727, 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 Aug 21, 2012 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00909727 live on ClinicalTrials.gov.