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



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 30
Updated:5/19/2018
Start Date:October 30, 2015
End Date:May 16, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis

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.

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. A
total of 195 pulmonary CF patients that meet all the inclusion and no exclusion criteria and
provide written informed consent will be randomized to receive 50 mg CTX-4430, 100 mg
CTX-4430, or placebo in a 1:1:1 ratio. Follow-up visits will be conducted approximately every
4 weeks from Week 4 to Week 52 (4 weeks after completion of treatment).

Inclusion Criteria:

- FEV1 ≥50 percent predicted at Screening

- At least 1 pulmonary exacerbation in the 12 months before Screening

Exclusion Criteria:

- 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
We found this trial at
40
sites
Spectrum Health Butterworth Hospital
100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Principal Investigator: Marc McClelland, MD
Phone: 616-391-6148
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Emory University
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Arlene Stecenko, MD
Phone: 404-712-8762
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Lael Yonker, MD
Phone: 617-726-3719
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University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Edward Naureckas, MD
Phone: 773-834-4053
University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Florida
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Jorge Lascano, MD
Phone: 352-294-5195
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: John Spurzem, MD
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Childrens Hospital Los Angeles
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Thomas Keens, MD
Phone: 323-361-3255
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Central Florida Pulmonary Group, PA
326 North Mills Avenue
Orlando, Florida 32803
Principal Investigator: Daniel Layish, MD
Phone: 407-841-1100
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Ronald Rubenstein, MD
Phone: 267-426-9626
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Children's Hospital of Pittsburgh of UPMC
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Joseph Pilewski, MD
Phone: 412-692-7060
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Maine Medical Center
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Jonathan Zuckerman, MD
Phone: 207-662-6550
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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Albany Medical College
47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Principal Investigator: Thomas Smith, MD
Phone: 518-262-6608
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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University of New Mexico
Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Hengameh Raissey, PharmD
Phone: 505-917-3429
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Providence Health and Services
Anchorage, Alaska 99508
Principal Investigator: Dion Roberts, MD
Phone: 907-212-3299
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University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Samya Nasr, MD
Phone: 734-615-3266
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Dell Children's Medical center
Austin, Texas 78723
Principal Investigator: Bennie McWilliams, MD
Phone: 512-380-9200
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University of Alabama
Birmingham, Alabama 35294
Principal Investigator: Isabel Virella-Lowell, MD
Phone: 205-638-9568
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Ahmet Uluer, DO
Phone: 617-355-2446
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Hôpital Erasme
Brussels, 1070
Principal Investigator: Christiane Knoop, MD
Phone: +32 2 555 57 39
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UC Cincinnati Children's Hospital
Cincinnati, Ohio 45267
Principal Investigator: Patricia Joseph, MD
Phone: 513-558-7036
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Cincinnati, OH
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National Jewish Health
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Jennifer Taylor-Cousar, MD
Phone: 303-398-1099
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Harper University Hospital
Detroit, Michigan 48201
Principal Investigator: Dana Kissner, MD
Phone: 313-745-2221
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Detroit, MI
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Cook Children's Hospital
Fort Worth, Texas 76104
Principal Investigator: Karen Schultz, MD
Phone: 682-885-1244
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Hershey Medical Center
Hershey, Pennsylvania 17033
Principal Investigator: Robert Vender, MD
Phone: 717-531-5646
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University of Kansas Medical Center
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
Principal Investigator: Joel Mermis, MD
Phone: 913-588-4020
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Universiy of Tennessee Medical Center UHS
Knoxville, Tennessee 37920
Principal Investigator: John Callison, MD
Phone: 865-305-5281
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Medical College of Wisconsin
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Julie Biller, MD
Phone: 414-955-7019
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Yale University
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Marie Egan, MD
Phone: 203-785-4971
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Columbia University Medical Center
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Emily DiMango, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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University of Oklahoma Health Sciences Center
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Nighat Mehdi, MD
Phone: 405-271-6216
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University
Palo Alto, California 94304
Principal Investigator: Richard Moss, MD
Phone: 650-736-0388
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St. Francis Medical Center
Peoria, Illinois 61614
Principal Investigator: Subramanyam Chittivelu, MD
Phone: 309-624-2409
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Drexel University
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Michael Stephen, MD
Phone: 215-762-5462
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Oregon Health and Sciences University
Portland, Oregon 97227
Principal Investigator: Gopal Allada, MD
Phone: 503-418-8108
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Virginia Commonwealth University
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Nauman Chaudary, MD
Phone: 804-628-3921
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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University of California, Davis Medical Center
2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Brian Morrisey, MD
Phone: 916-734-3351
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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Sanford Clinical Research
Sioux Falls, South Dakota 57104
Principal Investigator: James Wallace, MD
Phone: 605-312-1033
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SUNY Upstate Medical University
750 East Adams Street
Syracuse, New York 13210
Principal Investigator: James Sexton, MD
Phone: 315-464-7593
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Banner University of Arizona Medical Center
Tucson, Arizona 85724
Principal Investigator: Cori Daines, MD
Phone: 520-626-3910
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Wake Forest Hospital
Winston-Salem, North Carolina 27157
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