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Restore CFTR Protein Completed with Results
Vertex-770 and the G551D mutation (STRIVE) (Vertex VX08-770-102)
This phase 3 study looked at the safety and effectiveness of ivacaftor in adolescents and adults with CF and the G551D mutation. Participants were randomized to receive either 150 mg ivacaftor or matched placebo twice a day for 48 weeks.
Eligibility
See other primary eligibility criteria for more information.
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Age:
12 Years and Older -
Mutation(s):
One Copy F508del or No Copies F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
To be eligible, subjects must have the G551D-CFTR mutation in at least 1 allele (any known or unknown mutations allowed in second allele).
Study Results
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What We Learned:
Study results show that there was a significant improvement in lung function in the treatment group compared to the placebo group. Additionally, the frequency of adverse events was similar in both groups.
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Primary Findings:
Effectiveness:
This multi-center, multi-national Phase 3 study was conducted between June 2009 and January 2011. A total of 161 participants enrolled in the study (83 in the ivacaftor group and 78 in the placebo group); 93% of ivacaftor and 97% of placebo treated participants completed the study. The primary endpoint was mean absolute change from baseline compared to placebo in FEV1 percent predicted through week 24. Participants receiving ivacaftor had a statistically significant improvement in lung function (10.6 percentage points difference compared with placebo).
The improvement in lung function was maintained through week 48. Significant improvement in all key secondary endpoints (fewer pulmonary exacerbations, weight gain, reduction in sweat chloride) were also observed through week 48 in subjects who received ivacaftor. Improvements in quality of life scores (CFQ-R respiratory domain) were also reported.
Safety:
The incidence of adverse events through week 48 was similar in the two groups. Discontinuation of study drug through week 48 due to adverse events was less frequent in the ivacaftor treatment group (1 percent compared to 5 percent in the placebo group).
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Citation:
N Eng J Med 2011;DOI 10.1056/NEJMoa1105185;365(18):1663-1672
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
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
54 weeks -
Number of Study Visits:
10
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Vertex -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
12 Years and Older -
Mutation(s):
One Copy F508del or No Copies F508del -
FEV1% Predicted:
40 to 90%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
To be eligible, subjects must have the G551D-CFTR mutation in at least 1 allele (any known or unknown mutations allowed in second allele).
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