Trials / Terminated
TerminatedNCT02823470
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 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
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LUM/IVA | LUM 400 mg q12h/IVA 250 mg q12h through Week 48. |
| DEVICE | activated smart device | |
| DEVICE | de-activated smart device |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2017-08-01
- Completion
- 2017-08-01
- First posted
- 2016-07-06
- Last updated
- 2018-09-27
- Results posted
- 2018-09-27
Locations
11 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02823470. Inclusion in this directory is not an endorsement.