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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02443688
First Posted: May 14, 2015
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celtaxsys, Inc.
  Purpose
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.

Condition Intervention Phase
Cystic Fibrosis Drug: CTX-4430 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celtaxsys, Inc.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of CTX-4430 administered orally once-daily to cystic fibrosis (CF) patients by the incidence of treatment emergent adverse events as compared to placebo. [ Time Frame: 52 weeks ]
  • To evaluate the efficacy of CTX-4430 administered orally once-daily to CF patients as determined by the absolute change from Baseline in FEV1 (forced expiratory volume in 1 second) percent predicted [ Time Frame: 52 Weeks ]

Secondary Outcome Measures:
  • To evaluate the efficacy of CTX-4430 administered orally once-daily to CF patients as determined by the relative change from Baseline in FEV1 percent predicted [ Time Frame: 52 weeks ]
  • To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on FVC (forced vital capacity) percent predicted and FEF25-75% (forced expiratory flow during the middle half of the forced vital capacity) percent predicted [ Time Frame: 52 weeks ]
  • To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on time to first pulmonary exacerbation while in the study [ Time Frame: 52 weeks ]
  • To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on the number of pulmonary exacerbations [ Time Frame: 52 weeks ]
  • To evaluate the effect of CTX-4430 administered orally once-daily to CF patients on specified biomarkers [ Time Frame: 52 weeks ]

Enrollment: 200
Study Start Date: October 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg CTX-4430
Once daily oral capsule for 48 weeks
Drug: CTX-4430
Experimental: 100 mg CTX-4430
Once daily oral capsule for 48 weeks
Drug: CTX-4430
Placebo Comparator: Matching Placebo
Once daily oral capsule for 48 weeks
Drug: Placebo

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443688


  Hide Study Locations
Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Alaska
Providence Health and Services
Anchorage, Alaska, United States, 99508
United States, Arizona
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, California
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
Pediatric Pulmonary and Cystic Fibrosis Clinic, Stanford University
Palo Alto, California, United States, 94304
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Central Florida Pulmonary Group
Orlando, Florida, United States, 32803
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
St. Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04106
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 49286
Harper University Hospital
Detroit, Michigan, United States, 48201
Spectrum Health Butterworth Campus
Grand Rapids, Michigan, United States, 49546
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Albany Medical College
Albany, New York, United States, 12208
Columbia University Medical Center
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Wake Forest Hospital
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
UC Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45267
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Drexel University
Philadelphia, Pennsylvania, United States, 19104
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, South Dakota
Sanford Clinical Research
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Universiy of Tennessee Medical Center UHS
Knoxville, Tennessee, United States, 37920
United States, Texas
Dell Children's Medical Center
Austin, Texas, United States, 78723
Cook Children's Hospital
Fort Worth, Texas, United States, 76104
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Belgium
Hôpital Erasme
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
St. Michael's Hospital
Toronto, Ontario, Canada, m5B 1W8
France
Centre hospitalier de Dunkerque
Dunkerque, France
Hôpital Albert Michallon
Grenoble, France
Hopital Arnaud de Villeneuve
Montpellier, France, Cedex 5
Hôpital Cochin
Paris, France
CH Lyon Sud
Pierre Benite, France
Germany
Charite' University
Berlin, Germany, 10117
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
Hannover, Germany
Universitätsklinikum Jena CF Centre
Jena, Germany, 07740
Lungenärztliche Praxis München-Pasing
München-Pasing, Germany
Klinikum Stuttgart CF Ambulanz
Stuttgart, Germany
Italy
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
United Kingdom
Belfast City Hospital
Belfast, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Llandough Hospital
Cardiff, United Kingdom, CF64 2XX
St James's University Hospital
Leeds, United Kingdom, LS97TF
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
King's College Hospital
London, United Kingdom, SE5 9RS
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
Sponsors and Collaborators
Celtaxsys, Inc.
Investigators
Principal Investigator: Steven Rowe, MD University of Alabama at Birmingham, USA
Principal Investigator: Stuart Elborn, MD Royal Brompton Hospital, London UK
  More Information

Responsible Party: Celtaxsys, Inc.
ClinicalTrials.gov Identifier: NCT02443688     History of Changes
Other Study ID Numbers: CTX-4430-CF-201
First Submitted: May 8, 2015
First Posted: May 14, 2015
Last Update Posted: May 22, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases