Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
