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

NCT02443688 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-09-04

Study results available
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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.

Conditions

Interventions

DRUG

CTX-4430

DRUG

Placebo

Sponsors & Collaborators

  • Celtaxsys, Inc.

    lead OTHER

Principal Investigators

  • Steven Rowe, MD · University of Alabama at Birmingham, USA

  • Stuart Elborn, MD · Royal Brompton Hospital, London UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-30
Primary Completion
2018-04-20
Completion
2018-05-16

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02443688 on ClinicalTrials.gov