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

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Vertex Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Cystic Fibrosis

Treatments

Drug: ELX/TEZ/IVA
Drug: IVA

Study type

Interventional

Funder types

Industry

Identifiers

NCT04043806
2018-004652-38 (EudraCT Number)
VX18-445-113

Details and patient eligibility

About

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).

Enrollment

458 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

458 participants in 1 patient group

ELX/TEZ/IVA
Experimental group
Description:
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.
Treatment:
Drug: IVA
Drug: ELX/TEZ/IVA

Trial documents
2

Trial contacts and locations

97

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Data sourced from clinicaltrials.gov

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