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

Purpose

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).

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 participant 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
ELX/TEZ/IVA 		Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
  • 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
    Tablet for oral administration.
    Other names:
    • VX-770
    • ivacaftor

Recruiting Locations

More Details

NCT ID
NCT04043806
Status
Completed
Sponsor
Vertex Pharmaceuticals Incorporated