VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)

NCT04058210 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2019-11-21

No results posted yet for this study

Summary
Conditions
Interventions
Sponsors
Investigators
Design
Eligibility
Timeline
Countries
Locations
Related
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Summary

The purpose of this program is to provide elexacaftor(ELX, VX-445)/tezacaftor(TEZ)/ivacaftor(IVA) combination therapy to CF patients in critical need who are 12 years of age and older, heterozygous for F508del and a minimal function (MF) mutation in response to unsolicited physician requests.

Conditions

Cystic Fibrosis

Interventions

DRUG

ELX/TEZ/IVA

Fixed-dose combination tablet for oral administration.

DRUG

IVA

150-mg tablet for oral administration.

Sponsors & Collaborators

Vertex Pharmaceuticals Incorporated
lead INDUSTRY

Eligibility

Min Age: 12 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

More Related Trials

Entities

Diseases

Cystic Fibrosis

Companies

Vertex Pharmaceuticals Incorporated

Summary

Conditions

Interventions

Sponsors & Collaborators

Eligibility

Timeline & Regulatory

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

A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis

A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)

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