A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects with Cystic Fibrosis (VX18-445-113)
VXNextGenOLE445
What is the goal of the study?
This is a Phase 3 open-label clinical trial sponsored by Vertex Pharmaceuticals to evaluate the long term safety of an FDA approved drug combination, tezacaftor-ivacaftor, with the addition of the 445 compound in patients with cystic fibrosis (CF). Participants must have a genotype with the delF508 mutation and a minimal function mutation or be homozygous for the delF508 mutation. Eligible patients will rollover to this open label protocol from the VX659-105 NextGen open label study that is currently open at SCH because the VX445 compound was selected by Vertex to submit for global regulatory approvals. Study visits will occur at day 15, week 4 and then every 4 - 8 weeks through week 36, and then every 12 weeks; procedures will include pulmonary function testing, ECGs, sweat testing, and safety labs. 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.