A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation

Stopped early · Phase 4

Conditions studied: Cystic Fibrosis

In brief

The study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutation.

Key facts

Study ID

NCT02823470

Run by

Vertex Pharmaceuticals Incorporated

People needed

24

Starts

2016-06-01

Expected to finish

2017-08-01

Last updated by the study team

2018-09-27

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF).
• Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
• Confirmed diagnosis of CF and homozygous for the F508del-CFTR mutation
• Forced Expiratory Volume in one second/forced vital capacity (FEV1) ≥40% of predicted normal for age, sex, and height

You may not qualify if…

• Presence of moderate or severe hepatic impairment (Child-Pugh Class B or C)
• Subjects currently receiving invasive mechanical ventilation
• Known history of alcohol or drug abuse in the past year
• Clinically significant abnormal laboratory values during screening
• Pregnant or nursing females
• Female subjects and female partners of male subjects who plan to become pregnant during Treatment Period or within 90 days following the last dose of study drug
• History of solid organ or hematological transplantation
• Ongoing or prior participation in an investigational drug study within 30 days of screening
• Current use of commercial LUM/IVA combination therapy

Where it is running

• Study site — Hartford, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Jackson, Mississippi, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Columbia, South Carolina, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Victoria, British Columbia, Canada
• Study site — Saint John, New Brunswick, Canada
• Study site — Québec, Canada

Full record on ClinicalTrials.gov

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