A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

Details

Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres
Phase
Phase II

Full title

A Phase 2, Randomized, Double-blind Study to
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561rosis
Trial Reference Number
121366
Trial type
Medication
Intervention
CFTR Modulators
Last edited date
09/11/2020
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • Must have one of the following 9 CFTR mutations on at least 1 allele: G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D
  • On Ivacaftor therapy
  • FEV1 value ≥40% and ≤100%
Top exclusion criteria
  • History of clinically significant cirrhosis with or without portal hypertension
  • History of solid organ or hematological transplantation
  • Lung infection with organisms associated with a more rapid decline in pulmonary status

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