Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

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Vertex Pharmaceuticals

Status and phase

Terminated
Phase 3

Conditions

Cystic Fibrosis

Treatments

Drug: IVA
Drug: VX-659/TEZ/IVA

Study type

Interventional

Funder types

Industry

Identifiers

NCT03633526
2018-001711-67 (EudraCT Number)
VX18-659-106

Details and patient eligibility

About

This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes. The study was discontinued after completion of Part A due to Sponsor's discretion.

Enrollment

18 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)
  • Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex, and height.

Key Exclusion Criteria:

  • Clinically significant cirrhosis with or without portal hypertension
  • Lung infection with organisms associated with a more rapid decline in pulmonary status.
  • Solid organ or hematological transplantation.

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

18 participants in 1 patient group

VX-659/TEZ/IVA
Experimental group
Description:
Participants who received VX-659 120 milligram (mg)/TEZ 50 mg/ IVA 75 mg as fixed-dose combination (FDC) in the morning and IVA 75 mg as a mono tablet in the evening in the triple combination (TC) treatment period.
Treatment:
Drug: IVA
Drug: VX-659/TEZ/IVA

Trial documents
2

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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