Clareo Health | A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
6–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects who weigh ≥15 kg without shoes a the Screening Visit
Subjects with confirmed diagnosis of CF at the Screening Visit.
Subjects who are homozygous for the F508del CFTR mutation
Subjects with ppFEV1 of ≥70 percentage points adjusted for age, sex, and height
Subjects with a screening LCI2.5 result greater than or equal to 7.5
You may not be if
History of any comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject
Clinically significant abnormalities in hemoglobin, liver function, or renal function at the Screening Visit.
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before Day 1
History of solid organ or hematological transplantation at the Screening Visit
