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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.
May 8, 2015
May 14, 2015
May 22, 2017
October 2015
May 2018   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02443688 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult CF Patients
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).
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: CTX-4430
  • Drug: Placebo
  • Experimental: 50 mg CTX-4430
    Once daily oral capsule for 48 weeks
    Intervention: Drug: CTX-4430
  • Experimental: 100 mg CTX-4430
    Once daily oral capsule for 48 weeks
    Intervention: Drug: CTX-4430
  • Placebo Comparator: Matching Placebo
    Once daily oral capsule for 48 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2018
May 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 30 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Italy,   United Kingdom,   United States
 
 
NCT02443688
CTX-4430-CF-201
Yes
Not Provided
Not Provided
Celtaxsys, Inc.
Celtaxsys, Inc.
Not Provided
Principal Investigator: Steven Rowe, MD University of Alabama at Birmingham, USA
Principal Investigator: Stuart Elborn, MD Royal Brompton Hospital, London UK
Celtaxsys, Inc.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP