A Phase 3 2-part Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis Homozygous for F508del
This study is being done to learn more about the safety and effects of the combination of Lumacaftor (LUM) and Ivacaftor (IVA) in patients with Cystic Fibrosis between 1 to less than 2 years of age.
The purpose of this study is to evaluate the PK of lumacaftor (LUM) and ivacaftor (IVA) in subjects 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del.
Participants will be paid for their participation.
- IRB Number: 1806061910
- Research Study Identifier: TX9369
- Principal Investigator: Clement Ren, MD
Contact the research team to learn more about this study.
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