MedTrace Logo

A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation

NCT03537651 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-04-19

Study results available
· View outcomes & findings →

Summary

This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.

Conditions

Interventions

DRUG

TEZ/IVA

Fixed-dose combination tablet for oral administration.

DRUG

IVA

Tablet for oral administration.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-25
Primary Completion
2020-10-28
Completion
2023-09-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Germany
  • Ireland
  • Poland
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT03537651 on ClinicalTrials.gov