Study of CTX­4430 in Cystic Fibrosis Patients

• Research type

  Research Study

• Full 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

• IRAS ID

  191267

• Contact name

  Stuart Elborn

• Contact email

  s.elborn@qub.ac.uk

• Sponsor organisation

  Celtaxsys Inc.

• Eudract number

  2015-002677-38

• Clinicaltrials.gov Identifier

  NCT02443688

• Duration of Study in the UK

  1 years, 4 months, 16 days

• Research summary

  The aim of this study is to test how safe and how effective the drug CTX-4430, taken by mouth once per day for 48 weeks, is to cystic fibrosis (CF) patients compared to placebo.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  16/SC/0018

• Date of REC Opinion

  4 Feb 2016

• REC opinion

  Further Information Favourable Opinion