drugset / Trial / NCT03278314

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

NCT03278314

Expanded access Approved for marketing Vertex Pharmaceuticals Incorporated

Summary

To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Ivacaftor Other / unclassified Oral
Subject tezacaftor Other / unclassified Oral

Indications