NCT01117012

Rollover 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF). The secondary objective of the study was to evaluate the efficacy of long-term VX-770 treatment in subjects with CF.

Detailed description

This open-label, rollover study of orally administered VX-770 was conducted in participants with CF to evaluate the safety and efficacy of long-term VX-770 treatment. Participants who were previously enrolled in Study 102 (VX08-770-102/NCT00909532) and Study 103 (VX08-770-103/NCT00909727), and met certain criteria were eligible to enroll in this study (Study 105/VX08-770-105/NCT01117012).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Ivacaftor

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-05-05
• Last updated: 2015-07-07
• Results posted: 2015-07-07

Locations

58 sites across 8 countries: United States, Australia, Canada, Czechia, France, Germany, Ireland, United Kingdom