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VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)

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Vertex Pharmaceuticals

Status

Conditions

Cystic Fibrosis

Treatments

Drug: ELX/TEZ/IVA
Drug: IVA

Study type

Expanded Access

Funder types

Industry

Identifiers

NCT04058210
VX18-445-901

Details and patient eligibility

About

The purpose of this program is to provide elexacaftor(ELX, VX-445)/tezacaftor(TEZ)/ivacaftor(IVA) combination therapy to CF patients in critical need who are 12 years of age and older, heterozygous for F508del and a minimal function (MF) mutation in response to unsolicited physician requests.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients who have F/MF genotypes AND who meet at least 1 of the following criteria:
  • The percent predicted forced expiratory volume in 1 second (ppFEV1) is <40 for a minimum of 2 months before the date of the request, OR
  • Documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications

Exclusion criteria

  1. Patients with severe hepatic impairment (Child-Pugh Class C)
  2. History of any other comorbidity that, in the opinion of the treating physician, might pose undue risk in administering ELX/TEZ/IVA to the patient
  3. Pregnancy

Other protocol defined Inclusion/Exclusion criteria may apply

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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