A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Phase 3
Completed
NCT03525574
| Condition | Cystic Fibrosis |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Vertex Pharmaceuticals Incorporated |
|---|
| Status | Completed |
|---|
| Enrollment | 507 participants |
|---|
| Interventions | ELX/TEZ/IVA, IVA |
|---|
| Start date | Oct 9, 2018 |
|---|
| Completion date | Jan 9, 2023 |
|---|
| Results posted | May 8, 2024 |
|---|
Summary
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation
Treatment Period: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From Day 1 up to Week 196 · Participants
| ELX/TEZ/IVA | 504 Participants |
|---|
| ELX/TEZ/IVA | 175 Participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.