Clinical Trials and Studies

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Study Title Principal Investigator
VX-770 Expanded Access Program (EAP)
VX-770, a compound being developed by Vertex Pharmaceuticals Incorporated (Vertex) for the treatment of CF, is an orally bioavailable small molecule that targets the underlying defect in CF, the dysfunctional CFTR protein. In Phase 3 studies of VX-770 in patients with CF and a G551D CFTR mutation, improvements in CFTR function (measured by reduction in sweat chloride concentration) and improvements in lung function were observed. Patients who are interested in the VX-770 Expanded Access should contact their CF physician about participation. Physicians interested in participating as a site should contact 800-745-4484.
Approved for marketing | Cystic Fibrosis | Site Unknown
Adupa Rao
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A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Completed | Cystic Fibrosis | Multisite
Adupa Rao
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A 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic Fibrosis
Terminated | Cystic Fibrosis | Multisite
Novartis Pharmaceuticals
A Point Prevalence Study to Evaluate the Prevalence of Antibodies to Selected Porcine Viruses in Patients With Cystic Fibrosis Who Are Receiving Porcine-Derived Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors
This is a multicenter, non-interventional point-prevalence study conducted in the US to determine the seroprevalence of antibodies to selected porcine viruses in pancreatic enzyme replacement therapy-exposed CF patients and in an unexposed control group with chronic medical conditions matched for age and geographic region of residence. Data collection includes demographic and medical history, pancreatic enzyme replacement therapy, transfusion history, and history of potential exposure to pig viruses. If a patient meets all the requirements of the study and provides a study specific informed consent/assent, a single blood sample is obtained as part of a planned standard-of-care blood collection. This harmonized protocol reflects equal sponsorship not only by the registering Sponsor, AbbVie, but also the Collaborators, Aptalis Pharma and Janssen Research & Development, LLC.
Completed | Cystic Fibrosis | Multisite
Gerhard Leitz
A Prospective, 5-year Registry Study to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa (PA) Isolates From Patients With Cystic Fibrosis in the United States [AIR-CF5]
Completed | Cystic Fibrosis | Multisite
Gilead Director
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
The goal of this clinical study is to advance the acceptance of new biomarkers designed to detect drug-induced kidney injury in clinical trials. The Kidney Safety Project is being conducted at four major medical centers: - University of Southern California - University of Minnesota - MD Anderson Cancer Center - Dana-Farber Cancer Institute. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University of Southern California and the University of Minnesota and aims to evaluate aminoglycoside induced acute kidney injury in patients with cystic fibrosis. The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate cisplatin induced acute kidney injury in patients with head and neck cancer. The data from the Kidney Safety Project, from both the Aminoglycoside Study and the Cisplatin Study, will be combined for determination of the best biomarkers for predicting drug-induced acute kidney injury.
Unknown status | Cystic Fibrosis | Multisite
Paul Beringer
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