Trials / Approved For Marketing

Approved For MarketingNCT04702360

ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation

ELX/TEZ/IVA Expanded Access Program for Patients 6 Through 11 Years of Age With Cystic Fibrosis Who Have At Least One F508del Mutation

Status: Approved For Marketing
Phase: —
Study type: Expanded Access
Enrollment: —

Sponsor: Vertex Pharmaceuticals Incorporated · Industry
Sex: All
Age: 6 Years – 11 Years
Healthy volunteers: —

Summary

The purpose of this program is to provide elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) to CF patients in critical need who are 6 to 11 years of age with at least one F508del mutation in response to unsolicited physician requests.

Conditions

Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	ELX/TEZ/IVA	Fixed-dose combination tablet for oral administration.
DRUG	IVA	IVA monotablet for oral administration.

Timeline

First posted: 2021-01-08
Last updated: 2021-07-15

Source: ClinicalTrials.gov record NCT04702360. Inclusion in this directory is not an endorsement.