Women and Men ages 12 and older with Cystic Fibrosis needed for a research study.
A Phase 2, Single-Blind, Placebo-Controlled Study to Evaluate the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >=40% Predicted
UVa Health System, Department of Radiology, seeks women and men ages 12 and older with cystic fibrosis (CF) with the G155D mutation for research studies involving the new investigational drug VX770. VX770 is an investigational drug that is thought to work by improving the function and quantity of the CFTR protein. In people with CF, when this protein does not work right, mucus builds up. The purpose of this study is to look at how VX770 changes the way air moves in the lungs in patients with cystic fibrosis using inhaled hyperpolarized helium gas with Magnetic Resonance Imaging (MRI). The study involves spirometry, blood and urine testing, sweat chloride testing, electrocardiogram (ECG) and a physical exam along with the MRI with inhaled helium. Subjects will travel to the University of Virginia in Charlottesville, Virginia 5 times over the course of 8 weeks for study related tests. § Study-related travel, MRI, spirometry, blood and urine testing, sweat chloride testing, ECG and helium gas are provided free of charge. § Total Compensation for study completion is $975.00 and is prorated per study visit day. Contact Information: For more information please contact: o Joanne C. Gersbach, RN, CCRC o Phone: 434-243-6074 o Email: firstname.lastname@example.org o IRB HSR #15107 Principal Investigator: Talissa Altes, MD