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VX-770 in People with CF and G551D Mutation - Open Label Safety Study (PERSIST) (Vertex VX-770-105)
This study looked at the long-term safety of ivacaftor in people with CF and the G551D mutation. Subjects received ivacaftor for 96 weeks during this study.
Eligibility
See other primary eligibility criteria for more information.
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Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
To be included in this open-label extension study, a subject must have completed either VX-770-102 (STRIVE) or VX-770-103 (ENVISION).
Study Results
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What We Learned:
Study results show that there were no new safety concerns associated with ivacaftor. Additionally, ivacaftor was associated with sustained improvements in lung function.
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Primary Findings:
Effectiveness:
This study (conducted between July 2010 and April 2013) included a total of 192 participants who had completed one of two previous 48-week, placebo-controlled trials (either STRIVE or ENVISION). Participants received 150 mg of ivacaftor every 12 hours for an additional 96 weeks.
Participants who had received ivacaftor during STRIVE and ENVISION, showed sustained improvements in lung function (FEV1), weight and rate of pulmonary exacerbations for up to 144 weeks of treatment. Participants who had received placebo during STRIVE or ENVISION, but received ivacaftor during this open-label study had improvements in lung function and other clinical measures comparable to those seen during STRIVE and ENVISION.
Safety:
The primary endpoints were to assess long-term safety profile of ivacaftor as assessed by adverse events, clinical laboratory assessments, electrocardiograms, vital signs, and physical examination. The most common adverse events were pulmonary exacerbation, cough, and upper respiratory tract infection. The frequency of occurrence of adverse events was consistent or reduced with time as compared with the placebo period (during STRIVE and ENVISION) across all observation periods. At 144 weeks of treatment, ivacaftor was well tolerated and there were no new safety concerns.
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Citation:
Lancet 2014;DOI 10.1016/S2213-2600(14)70218-8;2(11):902-910
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
No -
Placebo Controlled: ?more info
No -
Length of Participation:
2 years -
Number of Study Visits:
10
Additional Information
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Phase: ?more info
Phase Three -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
6 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
To be included in this open-label extension study, a subject must have completed either VX-770-102 (STRIVE) or VX-770-103 (ENVISION).
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