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A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

NCT03447249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2020-03-13

Study results available
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Summary

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

Conditions

Interventions

DRUG

VX-659/TEZ/IVA

Participants received VX-659/TEZ/IVA orally once daily in the morning.

DRUG

IVA

Participants received IVA orally once daily in the evening.

DRUG

Placebo

Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2019-02-05
Completion
2019-02-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Germany
  • Ireland
  • Israel
  • Poland
  • Spain
  • 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 NCT03447249 on ClinicalTrials.gov