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
Фаза 2
Завершено
NCT02070744
| Заболевание | Cystic Fibrosis |
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| Фаза | Фаза 2 |
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| Спонсор | Vertex Pharmaceuticals Incorporated |
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| Статус | Завершено |
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| Участники | 40 участн. |
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| Вмешательство | VX-661, Ivacaftor, Placebo matched to VX-661, Placebo matched to Ivacaftor |
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| Дата начала | 03.2014 |
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| Дата завершения | 27.05.2016 |
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| Публикация результатов | 13.04.2018 |
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Кратко
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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