EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients
NCT ID: NCT02443688
Last Updated: 2019-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2015-10-30
2018-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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50 mg CTX-4430
Once daily oral capsule for 48 weeks
CTX-4430
100 mg CTX-4430
Once daily oral capsule for 48 weeks
CTX-4430
Matching Placebo
Once daily oral capsule for 48 weeks
Placebo
Interventions
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CTX-4430
Placebo
Eligibility Criteria
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Inclusion Criteria
* At least 1 pulmonary exacerbation in the 12 months before Screening
Exclusion Criteria
* 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
18 Years
30 Years
ALL
No
Sponsors
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Celtaxsys, Inc.
OTHER
Responsible Party
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Principal Investigators
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Steven Rowe, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham, USA
Stuart Elborn, MD
Role: PRINCIPAL_INVESTIGATOR
Royal Brompton Hospital, London UK
Locations
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University of Alabama
Birmingham, Alabama, United States
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
Wake Forest Hospital
Winston-Salem, North Carolina, United States
UC Cincinnati Children's Hospital
Cincinnati, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University
Philadelphia, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Sanford Clinical Research
Sioux Falls, South Dakota, United States
Universiy of Tennessee Medical Center UHS
Knoxville, Tennessee, United States
Dell Children's Medical Center
Austin, Texas, United States
Cook Children's Hospital
Fort Worth, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hôpital Erasme
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
University of Calgary
Calgary, Alberta, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Centre hospitalier de Dunkerque
Dunkirk, , France
Hôpital Albert Michallon
Grenoble, , France
Hopital Arnaud de Villeneuve
Montpellier, , France
Hôpital Cochin
Paris, , France
CH Lyon Sud
Pierre-Bénite, , France
Charite' University
Berlin, , Germany
Krankenhaus Donaustauf
Donaustauf, , Germany
Carl-Gustav-Klinikum Dresden, Mukoviszidose Centrum "Christiane Herzog"
Dresden, , Germany
Ruhrlandklinik Essen
Essen, , Germany
Institut für klinische Forschung Pneumologie
Frankfurt, , Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Jena CF Centre
Jena, , Germany
Lungenärztliche Praxis München-Pasing
München-Pasing, , Germany
Klinikum Stuttgart CF Ambulanz
Stuttgart, , Germany
Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliero Universitaria
Catania, , Italy
Azienda Ospedaliera A Meyer
Florence, , Italy
IRCCS Ospedale Pediatrico Bambino
Rome, , Italy
Ospedale Civile Maggiore
Verona, , Italy
Belfast City Hospital
Belfast, , United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Llandough Hospital
Cardiff, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
University Hospital of South Manchester
Manchester, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CTX-4430-CF-201
Identifier Type: -
Identifier Source: org_study_id
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