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A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy

NCT03447262 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2022-01-25

Study results available
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Summary

This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.

Conditions

Interventions

DRUG

VX-659/TEZ/IVA

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

DRUG

IVA

IVA tablet qd in the evening.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2020-09-09
Completion
2020-09-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Germany
  • Ireland
  • Israel
  • Poland
  • 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 NCT03447262 on ClinicalTrials.gov