MedTrace Logo

A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes

NCT04353817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-07-26

Study results available
· View outcomes & findings →

Summary

This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function (MF) mutation (F/MF genotypes).

Conditions

Interventions

DRUG

ELX/TEZ/IVA

Fixed-dose combination tablet for oral administration qd in the morning.

DRUG

IVA

Tablet for oral administration qd in the evening.

OTHER

Placebo (matched to ELX/TEZ/IVA)

Placebo matched to ELX/TEZ/IVA for oral administration once daily (qd) in the morning.

OTHER

Placebo (matched to IVA)

Placebo matched to IVA for oral administration qd in the evening.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-19
Primary Completion
2021-05-17
Completion
2021-05-17
FDA Drug
Yes

Countries

  • Australia
  • Canada
  • Denmark
  • France
  • Germany
  • Israel
  • Netherlands
  • Spain
  • 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 NCT04353817 on ClinicalTrials.gov