MedTrace Logo

Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)

NCT02139306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2020-05-14

Study results available
· View outcomes & findings →

Summary

This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

Conditions

Interventions

DRUG

Ataluren (PTC124®)

Oral Ataluren TID

DRUG

Placebo

Oral Placebo TID

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • ECFS-Clinical Trial Network (ECFS-CTN)

    collaborator UNKNOWN

  • PTC Therapeutics

    lead INDUSTRY

Principal Investigators

  • Joseph McIntosh, MD · PTC Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT02139306 on ClinicalTrials.gov