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Phase 3 open-label lumacaftor + ivacaftor study in children aged 1 to less than 2 years with cystic fibrosis homozygous for F508del
2017-004794-13Phase 3
- Sponsor
- Vertex Pharmaceuticals
- Start
- May 2020
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 3, open-label, single-arm trial of lumacaftor and ivacaftor in cystic fibrosis (CF), sponsored by Vertex Pharmaceuticals. Primary endpoint: Part A: Area under the concentration versus time curve during a dosing interval (AUCtau) of lumacaftor and ivacaftor.
02
Drugs
lumacaftorivacaftor
03
Conditions
cystic fibrosis (CF)
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