Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT00457821 |
Recruitment Status
:
Completed
First Posted
: April 9, 2007
Results First Posted
: October 5, 2012
Last Update Posted
: October 5, 2012
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Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
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Tracking Information | ||||
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First Submitted Date ICMJE | April 5, 2007 | |||
First Posted Date ICMJE | April 9, 2007 | |||
Results First Submitted Date | February 27, 2012 | |||
Results First Posted Date | October 5, 2012 | |||
Last Update Posted Date | October 5, 2012 | |||
Study Start Date ICMJE | May 2007 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Safety and tolerability assessments based on clinical evaluations, laboratory assessments, and adverse events during administration of VX-770 | |||
Change History | Complete list of historical versions of study NCT00457821 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety Study of Ivacaftor in Subjects With Cystic Fibrosis | |||
Official Title ICMJE | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D | |||
Brief Summary | The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 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 AMP-dependent protein kinase A (PKA) activation. | |||
Detailed Description | This was a double-blind, placebo-controlled, cross-over, multiple dose study of up to 28 days of dosing, in subjects with cystic fibrosis (CF) who have a G551D-CTFR gene mutation. Enrollment of 39 subjects occurred at 15 centers in the US, Canada, and Germany. The study was conducted in 2 parts:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cystic Fibrosis | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
39 | |||
Original Enrollment ICMJE |
36 | |||
Actual Study Completion Date | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Germany, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00457821 | |||
Other Study ID Numbers ICMJE | VX06-770-101 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Vertex Pharmaceuticals Incorporated | |||
Study Sponsor ICMJE | Vertex Pharmaceuticals Incorporated | |||
Collaborators ICMJE | Cystic Fibrosis Foundation Therapeutics | |||
Investigators ICMJE |
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PRS Account | Vertex Pharmaceuticals Incorporated | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |