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Anti-Inflammatory Closed to Enrollment

Phase 2 study of CTX-4430 in people with CF (EMPIRE) (Celtaxsys CTX-4430)

This study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of the anti-inflammatory drug CTX-4430 and will use a placebo control.

 This study will look at the safety and effectiveness of the anti-inflammatory drug CTX-4430. Researchers will test CTX-4430 at two different doses. This study is placebo-controlled, meaning that some participants will receive the study drug, and others will receive a placebo. Researchers will test the effectiveness of CTX-4430 by measuring lung function. They will also test the drug’s safety by tracking adverse events.This trial is for people with CF who have had a pulmonary exacerbation in the last year. It may require blood draws, lung function tests and/or other measurements.

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 30 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Eligible patients will have had at least 1 acute pulmonary exacerbation in the 12 months prior to screening

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    1 years

  • Number of Study Visits:

    15

Additional Information

Study Sites

  • Closed to Enrollment

    Alabama

    The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233

  • Closed to Enrollment

    Alaska

    Providence Alaska Medical Center, Anchorage, AK 99508

  • Closed to Enrollment

    Arizona

    Tucson Cystic Fibrosis Center, Tucson, AZ 85724

  • Closed to Enrollment

    California

    Children's Hospital of Los Angeles, Los Angeles, CA 90027

  • Closed to Enrollment

    California

    University of California at Davis Medical Center, Sacramento, CA 95817

  • Closed to Enrollment

    California

    Stanford University Medical Center, Palo Alto, CA 94304

  • Closed to Enrollment

    Colorado

    National Jewish Health, Denver, CO 80206

  • Closed to Enrollment

    Connecticut

    Yale University School of Medicine, New Haven, CT 06520

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Florida

    University of Florida, Gainesville, FL 32610

  • Closed to Enrollment

    Georgia

    Children’s Healthcare of Atlanta and Emory University, Atlanta, GA 30322

  • Closed to Enrollment

    Illinois

    University of Chicago, Chicago, IL 60637

  • Closed to Enrollment

    Illinois

    OSF HealthCare Children’s Hospital of Illinois, Saint Francis Medical Center, Peoria, IL 61637

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Maine

    Maine Medical Center, Portland, ME 04102

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Massachusetts

    Massachusetts General Hospital, Boston, MA 02114

  • Closed to Enrollment

    Michigan

    University of Michigan, Michigan Medicine, Ann Arbor, MI 48109

  • Closed to Enrollment

    Michigan

    Helen DeVos Children's Hospital, Grand Rapids, MI 49546

  • Closed to Enrollment

    Michigan

    Children's Hospital of Michigan, Detroit, MI 48201

  • Closed to Enrollment

    Mississippi

    University of Mississippi Medical Center, Jackson, MS 39216

  • Closed to Enrollment

    New Mexico

    University of New Mexico School of Medicine, Albuquerque, NM 87131

  • Closed to Enrollment

    New York

    Columbia University Cystic Fibrosis Program, New York, NY 10032

  • Closed to Enrollment

    North Carolina

    Wake Forest University Baptist Medical Center, Winston-Salem, NC 27157

  • Closed to Enrollment

    Ohio

    University of Cincinnati Medical Center, Cincinnati, OH 45267

  • Closed to Enrollment

    Oklahoma

    Oklahoma Cystic Fibrosis Center, OKC, OK 73104

  • Closed to Enrollment

    Oregon

    Oregon Health Sciences University, Portland, OR 97239

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Philadelphia, Philadelphia, PA 19104

  • Closed to Enrollment

    Pennsylvania

    Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA 15224

  • Closed to Enrollment

    Pennsylvania

    Hershey Medical Center Pennsylvania State University, Hershey, PA 17033

  • Closed to Enrollment

    South Dakota

    Sanford USD Medical Center, Sioux Falls, SD 57117

  • Closed to Enrollment

    Tennessee

    University of Tennessee Medical Center, Knoxville, TN 37920

  • Closed to Enrollment

    Texas

    Cook Children's Medical Center, Fort Worth, TX 76104

  • Closed to Enrollment

    Texas

    Dell Children's Medical Center of Central Texas, Austin, TX 78723

  • Closed to Enrollment

    Virginia

    Virginia Commonwealth University, Richmond, VA 23219

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years to 30 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

Eligible patients will have had at least 1 acute pulmonary exacerbation in the 12 months prior to screening

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