Study of VX-770 in Cystic Fibrosis Subjects
An Open-Label, Rollover Study to Evaluate the Long-Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis.
Vertex Pharmaceutical Incorporated
200 participants
Jul 1, 2010
Interventional
Conditions
Summary
Study 105 (VX08-770-105) is an open-label, VX-770 treatment extension of Study VX08-770-102 (Study 102) and Study VX08-770-103 (Study 103). This rollover study evaluates the long-term safety and efficacy of treatment with the experimental drug, VX-770, for a duration of up to 96 weeks. Male and female subjects 6 years and older with cystic fibrosis who have completed Study 102 or 103 without major protocol violations are eligible to enrol. This project is an international, multi-centre trial, with subjects from 70 sites worldwide including Australia, Europe and North America. [Study 102: NCT00909532] [Study 103: NCT00909727]
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
VX-770 150mg, oral tablets, twice per day, for the sooner of approximately 96 weeks or until VX 770 is commercially available in each respective country
Locations(7)
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ACTRN12610000491066