A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older (VX19-445-107)
VX445-107 Triple Combination Therapy in CF Patients 6 Years of Age and Older
What is the goal of the study?
This is a Phase 3 open label clinical trial sponsored by Vertex Pharmaceuticals to evaluate the safety and efficacy of VX445/TEZ/IVA triple combination therapy in patients with Cystic Fibrosis (CF) who are 6 years of age and older. Eligible participants will rollover to this open label protocol following completion of a feeder study (at SCH VX18-445-106 Part B). Participants must be homozygous for F508del (F/F genotype) or heterozygous for F508del and a minimal function (MF) mutation that is not responsive to IVA and TEZ/IVA (F/MF genotypes). Study visits will occur on day 1, week 8, and then every 8 weeks through week 36 and then every 12 weeks; procedures will include pulmonary function testing, multiple breath washout, ECGs, sweat testing, safety labs, fecal sample, ophthalmologic examination, and sample collection for exploratory markers. Telephone calls will be made every 4 weeks between CRC study visits. Adverse events and changes in treatment will be assessed throughout the study period.
Who can participate in the study?
Please contact the study team listed below to learn more.