Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion
Phase 2
Completed
NCT02070744
| Condition | Cystic Fibrosis |
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| Phase | Phase 2 |
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| Sponsor | Vertex Pharmaceuticals Incorporated |
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| Status | Completed |
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| Enrollment | 40 participants |
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| Interventions | VX-661, Ivacaftor, Placebo matched to VX-661, Placebo matched to Ivacaftor |
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| Start date | Mar, 2014 |
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| Completion date | May 27, 2016 |
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| Results posted | Apr 13, 2018 |
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Summary
The objective of this study was to evaluate the safety and efficacy of VX-661in combination with ivacaftor in participants with cystic fibrosis (CF) who are homozygous for F508del cystic fibrosis transmembrane conductance regulator (CFTR) mutation
PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline (PC Phase) up to 112 days · Participants
| PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h | 6 Participants |
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| PC Phase: VX-661 Placebo q12h + IVA Placebo q12h | 5 Participants |
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| PC Phase: VX-661 100 mg qd + IVA 150 mg q12h | 15 Participants |
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| PC Phase: VX -661 Placebo qd + IVA Placebo q12h | 13 Participants |
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| PC Phase: VX-661 50 mg q12h + IVA 150 mg q12h | 1 Participants |
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| PC Phase: VX-661 Placebo q12h + IVA Placebo q12h | 2 Participants |
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OLE Phase: Number of Participants With Treatment-Emergent AEs and SAEs
Baseline (OLE Phase) up to 364 days · Participants
| OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h | 25 Participants |
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| OLE Phase: VX-661 100 mg qd + IVA 150 mg q12h | 6 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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