A Study Evaluating the Long-term Safety and Efficacy 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

NCT03525574
2018-000185-11 (EudraCT Number)
VX17-445-105

Details and patient eligibility

About

The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

Enrollment

507 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completed study drug treatment in a parent study i.e.VX17-445-102 (NCT03525444) and VX17-445-103 (NCT03525548); or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

Exclusion criteria

  • History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
  • Current participation in an investigational drug trial (other than a parent study)

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)

507 participants in 1 patient group

ELX/TEZ/IVA
Experimental group
Description:
Treatment Period: Participants received ELX 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hrs (q12h) in the treatment period for 192 weeks. Extension Period: Participants from certain countries participated in extension period and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the extension period for 48 weeks.
Treatment:
Drug: IVA
Drug: ELX/TEZ/IVA

Trial documents
2

Trial contacts and locations

110

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Data sourced from clinicaltrials.gov

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