Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation
Public ClinicalTrials.gov record NCT00953706. 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 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR 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
- NCT00953706
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 140 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
- Sep 2009 (Type not available)
- Primary completion
- Jul 2010 (Actual)
- Completion
- May 2013 (Actual)
- Last update posted
- Sep 11, 2015
2009 – 2013
United States locations
- U.S. sites
- 34
- U.S. states
- 24
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| Providence Medical Center | Anchorage | Alaska | 99508 | — |
| Kaiser Permanente Medical Care Program | Oakland | California | 94611 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Nemours Children's Clinic | Orlando | Florida | 32801 | — |
| St. Luke's CF clinic | Boise | Idaho | 83712 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Massachussetts Medical School | Worcester | Massachusetts | 01655 | — |
| Helen DeVos Children's Hospital; Spectrum Health Hospitals | Grand Rapids | Michigan | 49503 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| New York Medical College | Hawthorne | New York | 10532 | — |
| The CF Center, Beth Israel Medical Center | New York | New York | 10003 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Toldedo Children's Hospital | Toledo | Ohio | 43606 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of Tennessee | Memphis | Tennessee | 38103 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Univeristy of Utah | Salt Lake City | Utah | 84132 | — |
| Vermont Lung Center at the University of Vermont | Colchester | Vermont | 05446 | — |
| Medical College of Virginia | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00953706, 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 11, 2015 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00953706 live on ClinicalTrials.gov.