MedTrace Logo

A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis

NCT03559062 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2020-02-11

Study results available
· View outcomes & findings →

Summary

This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).

Conditions

Interventions

DRUG

TEZ/IVA

Participants weighing \<40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.

DRUG

IVA

Participants weighing \<40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.

DRUG

Placebo

Placebo matched to TEZ/IVA FDC

DRUG

Placebo

Placebo matched to IVA

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
2018-05-17
Primary Completion
2018-12-21
Completion
2018-12-21
FDA Drug
Yes

Countries

  • Australia
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Poland
  • Switzerland
  • 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 NCT03559062 on ClinicalTrials.gov