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A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)

NCT03150719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-09-12

Study results available
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Summary

Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).

Conditions

Interventions

DRUG

Tezacaftor/Ivacaftor

TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.

DRUG

Ivacaftor

IVA 150 mg tablet.

DRUG

Placebo

Placebo matched to TEZ/IVA fixed-dose combination tablet.

DRUG

Placebo

Placebo matched to IVA tablet.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2018-08-09
Completion
2018-08-09
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany

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 NCT03150719 on ClinicalTrials.gov