EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

This study is a Phase 2, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of CTX-4430 administered once-daily for 48 weeks for treatment of CF.

Key facts

Study ID

NCT02443688

Run by

Celtaxsys, Inc.

People needed

200

Starts

2015-10-30

Expected to finish

2018-05-16

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Forced expiratory volume at one second (FEV1) ≥50 percent predicted at Screening
• At least 1 pulmonary exacerbation in the 12 months before Screening

You may not qualify if…

• Pregnant or nursing women
• Medical condition that is unstable, could be adversely impacted by participation in the study, or could impact assessment of the study results
• History of organ transplantation
• History of alcoholism or drug abuse within 2 years before Screening
• Regular use of a high-dose NSAID within 60 days before Screening

Where it is running

• Providence Health and Services — Anchorage, Alaska, United States
• Banner University of Arizona Medical Center — Tucson, Arizona, United States
• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University — Palo Alto, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• National Jewish Health — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Central Florida Pulmonary Group — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• St. Francis Medical Center — Peoria, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Harper University Hospital — Detroit, Michigan, United States
• Spectrum Health Butterworth Campus — Grand Rapids, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Albany Medical College — Albany, New York, United States
• Columbia University Medical Center — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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