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Lumacaftor/Ivacaftor in children aged 2–5 years with cystic fibrosis (F508del homozygous)
2016-001004-33Phase 3
- Sponsor
- Vertex Pharmaceuticals
- Start
- Jan 2018
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of lumacaftor + ivacaftor in cystic fibrosis (CF), sponsored by Vertex Pharmaceuticals. Primary endpoints: Part A: PK parameters of lumacaftor and ivacaftor (estimated peak concentrations) and Part A: Safety of lumacaftor/ivacaftor.
02
Drugs
lumacaftor + ivacaftor
03
Conditions
cystic fibrosis (CF)
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