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

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

sites

Cook Children's Hospital

Fort Worth, Texas 76104

Principal Investigator: Karen Schultz, MD

Phone: 682-885-1244

348

from

Fort Worth, TX

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,...

801

from

Atlanta, GA

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200

Principal Investigator: Lael Yonker, MD

Phone: 617-726-3719

1443

from

Boston, MA

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...

609

from

Chicago, IL

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...

1049

from

Gainesville, FL

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...

571

from

Jackson, MS

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...

1169

from

Los Angeles, CA

Central Florida Pulmonary Group, PA

326 North Mills Avenue
Orlando, Florida 32803

Principal Investigator: Daniel Layish, MD

Phone: 407-841-1100

1142

from

Orlando, FL

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...

1225

from

Philadelphia, PA

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...

974

from

Pittsburgh, PA

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...

1492

from

Portland, ME

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...

1309

from

Albany, NY

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...

526

from

Albuquerque, NM

Providence Health and Services

Anchorage, Alaska 99508

Principal Investigator: Dion Roberts, MD

Phone: 907-212-3299

2735

from

Anchorage, AK

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...

808

from

Ann Arbor, MI

Dell Children's Medical center

Austin, Texas 78723

Principal Investigator: Bennie McWilliams, MD

Phone: 512-380-9200

514

from

Austin, TX

University of Alabama

Birmingham, Alabama 35294

Principal Investigator: Isabel Virella-Lowell, MD

Phone: 205-638-9568

683

from

Birmingham, AL

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....

1444

from

Boston, MA

Hôpital Erasme

Brussels, 1070

Principal Investigator: Christiane Knoop, MD

Phone: +32 2 555 57 39

4718

from

Brussels,

UC Cincinnati Children's Hospital

Cincinnati, Ohio 45267

Principal Investigator: Patricia Joseph, MD

Phone: 513-558-7036

726

from

Cincinnati, OH

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,...

407

from

Denver, CO

Harper University Hospital

Detroit, Michigan 48201

Principal Investigator: Dana Kissner, MD

Phone: 313-745-2221

841

from

Detroit, MI

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...

737

from

Grand Rapids, MI

Hershey Medical Center

Hershey, Pennsylvania 17033

Principal Investigator: Robert Vender, MD

Phone: 717-531-5646

1147

from

Hershey, PA

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...

190

from

Kansas City, KS

Universiy of Tennessee Medical Center UHS

Knoxville, Tennessee 37920

Principal Investigator: John Callison, MD

Phone: 865-305-5281

777

from

Knoxville, TN

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...

636

from

Milwaukee, WI

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...

1344

from

New Haven, CT

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...

1286

from

New York, NY

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...

153

from

Oklahoma City, OK

Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University

Palo Alto, California 94304

Principal Investigator: Richard Moss, MD

Phone: 650-736-0388

1330

from

Palo Alto, CA

St. Francis Medical Center

Peoria, Illinois 61614

Principal Investigator: Subramanyam Chittivelu, MD

Phone: 309-624-2409

485

from

Peoria, IL

Drexel University

3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102

Principal Investigator: Michael Stephen, MD

Phone: 215-762-5462

1223

from

Philadelphia, PA

Oregon Health and Sciences University

Portland, Oregon 97227

Principal Investigator: Gopal Allada, MD

Phone: 503-418-8108

1384

from

Portland, OR

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...

1113

from

Richmond, VA

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...

1283

from

Sacramento, CA

Sanford Clinical Research

Sioux Falls, South Dakota 57104

Principal Investigator: James Wallace, MD

Phone: 605-312-1033

405

from

Sioux Falls, SD

SUNY Upstate Medical University

750 East Adams Street
Syracuse, New York 13210

Principal Investigator: James Sexton, MD

Phone: 315-464-7593

1193

from

Syracuse, NY

Banner University of Arizona Medical Center

Tucson, Arizona 85724

Principal Investigator: Cori Daines, MD

Phone: 520-626-3910

833

from

Tucson, AZ

Wake Forest Hospital

Winston-Salem, North Carolina 27157

from

Winston-Salem, NC

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

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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

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