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

• Status: Completed
• Trial end date: 2018-05-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celtaxsys, Inc.

Criteria

Inclusion Criteria:

• Forced expiratory volume at one second (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