Overview

A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

Status:
Completed
Trial end date:
2018-12-28
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Treatments:
Elexacaftor
Ivacaftor
Criteria
Key Inclusion Criteria:

- Homozygous for the F508del mutation (F/F)

- Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
age, sex, and height

Key Exclusion Criteria:

- Clinically significant cirrhosis with or without portal hypertension

- Lung infection with organisms associated with a more rapid decline in pulmonary status

- Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply