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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02823470
• Date of registration: 01/07/2016
• Prospective Registration: No
• Primary sponsor: Vertex Pharmaceuticals Incorporated
• Public title: 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
• Scientific title: A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del CFTR Mutation
• Date of first enrolment: June 2016
• Target sample size: 24
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02823470
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Device: de-activated smart device

Device: activated smart device

Drug: LUM/IVA

Primary Outcome(s)

Percentage Adherence to Lumacaftor/Ivacaftor (LUM/IVA) Treatment [Time Frame: Up to 35 weeks]

Secondary Outcome(s)

Number of Participants With Greater Than or Equal to (>=) 90 Percent (%) Adherence [Time Frame: Up to Week 12]

Percentage Adherence to Lumacaftor/Ivacaftor (LUM/IVA) Treatment Through 12 Weeks [Time Frame: Up to Week 12]

Number of Participants With Greater Than or Equal to (>=) 80 Percent (%) Adherence [Time Frame: Up to Week 12]

Secondary ID(s)

VX15-809-114

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02823470