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

• Status: Terminated
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Ivacaftor

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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