4 results
Primary ObjectiveTo evaluate the efficacy of lumacaftor/ivacaftor combination therapy (LUM/IVA) in subjects with cystic fibrosis (CF) 12 years of age and older who have at least one A455E mutation.Other Objectives* To explore the association between…
The primary objective is to evaluate safety and tolerability of treatment with AP01.This study will also evaluate the effect of AP01 on various efficacy measures as follows:* To evaluate the safety and tolerability of treatment with AP01 when given…
In this study, we want to investigate the effect of the change in co-medication from lumacaftor to tezacaftor on the kinetics and exposure levels of ivacaftor described by the through concentrationsPrimary Objective: - the through concentration of…
• Allow patients to continue or start AP01 therapy for the treatment of ILD and IPF prior to regulatory approval or until the study is terminated• To evaluate safety outcomes of patients on AP01 therapy