Rollover Study of VX-770 in Cystic Fibrosis Subjects
|ClinicalTrials.gov Identifier: NCT01117012|
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : July 7, 2015
Last Update Posted : July 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Ivacaftor||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects With Cystic Fibrosis|
|Study Start Date :||July 2010|
|Primary Completion Date :||May 2014|
|Study Completion Date :||May 2014|
VX-770 (ivacaftor) 150 milligram (mg) tablet orally twice daily (q12h).
Other Name: VX-770
- Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Study 105: Day 1 up to Week 168 ]Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.
- Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96 [ Time Frame: Study 105: Baseline through Week 96 ]FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as Study 105 Day 15.
- Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96 [ Time Frame: Study 105: Baseline through Week 96 ]FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in Study 105. Absolute Change at Week 48 and Week 96 are reported.
- Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96 [ Time Frame: Study 105: Baseline through Week 96 ]The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Absolute Change at Week 48 and Week 96 are reported.
- Annualized Pulmonary Exacerbation Event Rate [ Time Frame: Study 105: Day 1 through Week 96 ]Annualized event rate was calculated by regression with negative binomial distribution.
- Annualized Duration of Pulmonary Exacerbation Events [ Time Frame: Study 105: Day 1 through Week 96 ]
- Absolute Change From Study 105 Baseline in Weight Through Week 96 [ Time Frame: Study 105: Baseline through Week 96 ]Weight is a measurement of nutritional status. Absolute change in weight, measured in kilograms (kg), at Week 48 and Week 96 are reported.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117012
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|Principal Investigator:||Edward McKone, MD||St. Vincent's University Hospital|