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

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.

Timeline

Start

2015-10-30

Primary completion

2018-04-20

Completion

2018-05-16

Outcome

Missed primary endpoint

registry analysis (superiority test); Pooled CTX-4430; p = 0.45; Mean Difference (Final Values) 0.16 (95% CI -2.20 to 2.50) NCT02443688 ↗

Drugs

Indications