Status:
COMPLETED
Study of the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis and the G551D Mutation
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
Cystic Fibrosis (CF) is caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The encoded protein, CFTR, is an epithelial chloride ion channel responsible for aid...
Eligibility Criteria
Inclusion
- Male or female with Cystic Fibrosis
- Must have the G551D-CFTR mutation on at least 1 allele
- FEV1 ≥40% of predicted normal for age, gender, and height at Screening
- 12 years of age or older
- Must be able to swallow tablets
Exclusion
- History of solid organ or hematological transplantation
- Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
- Use of inhaled hypertonic saline treatment within 14 days prior to the Screening Visit
- Extensive body tattoos or other physical features that will confound MRI
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01161537
Start Date
October 1 2010
End Date
February 1 2013
Last Update
July 31 2014
Active Locations (1)
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1
Charlottesville, Virginia, United States