Status:
APPROVED_FOR_MARKETING
ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-11 years
Brief 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 ...
Eligibility Criteria
Inclusion
- Key
- Patients with confirmed diagnosis of CF who have an F/any genotype
- Prior treatment for at least 6 months with an approved alternative CFTR modulator (if the patient is eligible for such treatment)
- Patients with percent predicted forced expiratory volume in 1 second (ppFEV1) \<40 for a minimum of 60 consecutive days before the date of completion of the request form
- Key
Exclusion
- Patients with severe hepatic impairment
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04702360
Last Update
July 15 2021
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