A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

Purpose

This study will evaluate the long-term safety and tolerability of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA).

Condition

  • Cystic Fibrosis

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Currently participating in study VX17-659-105 (NCT03447262)

Exclusion Criteria

  • History of drug intolerance in study VX17-659-105 that would pose an additional risk to the subject in the opinion of the investigator
  • Current participation in an investigational drug trial (other than study VX17-659-105)

Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Open-Label Triple Combination
Subjects will receive ELX/TEZ/IVA TC in the morning and IVA as mono tablet in the evening.
  • Drug: ELX/TEZ/IVA
    Fixed-dose combination (FDC) tablet for oral administration
    Other names:
    • VX-445/VX-661/VX-770
    • elexacaftor/tezacaftor/ivacaftor
  • Drug: IVA
    150-mg tablet for oral administration
    Other names:
    • VX-770
    • ivacaftor

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536

More Details

NCT ID
NCT04043806
Status
Recruiting
Sponsor
Vertex Pharmaceuticals Incorporated

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com