ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation
NCT04702360 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2021-07-15
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
Interventions
- DRUG
-
ELX/TEZ/IVA
Fixed-dose combination tablet for oral administration.
- DRUG
-
IVA
IVA monotablet for oral administration.
Sponsors & Collaborators
-
Vertex Pharmaceuticals Incorporated
lead INDUSTRY
Eligibility
- Min Age
- 6 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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