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Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

A Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label Extension

NCT02070744•Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Homozygous for the F508del CFTR mutation
•FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height
•Stable CF disease as judged by the investigator

Exclusion Criteria

•History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant
•Pregnant and nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1 of the PC Phase and Day -7 or Day 1 of the OLE Phase (whichever was applicable)
•Sexually active participants of reproductive potential who are not willing to follow the contraception requirements
•The participant or a close relative of the participant is the investigator or sub investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study.

Locations (23)

Birmingham, Alabama, United States

Palo Alto, California, United States

Stanford, California, United States

Altamonte Springs, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Tampa, Florida, United States

Boise, Idaho, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

May 27, 2016

Completion Date

May 27, 2016

Last Updated

September 24, 2025

Enrollment

ACTUAL participants

Conditions

Cystic Fibrosis

Interventions

VX-661

DRUG

Ivacaftor

DRUG

Placebo matched to VX-661

DRUG

Placebo matched to Ivacaftor

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

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