Identification Module
The Identification Module contains basic identifying information about the clinical trial, including the NCT ID, brief title, official title, acronym, organization study ID information, and organization details. This module provides essential identifiers for the trial.
Identification Module path is as follows:
Study -> Protocol Section -> Identification Module
Identification Module
Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-24 @ 9:31 PM
NCT ID:
NCT02797132
Brief Title:
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Official Title:
A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Study:
NCT02797132
Protocol Section:
NCT02797132