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A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

NCT03460990 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2019-10-17

Study results available
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Summary

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).

Conditions

Interventions

DRUG

VX-659/TEZ/IVA

Participants received VX-659/TEZ/IVA orally once daily in the morning.

DRUG

TEZ/IVA

Participants received TEZ/IVA orally once daily in the morning.

DRUG

IVA

Participants received IVA orally once daily in the evening.

DRUG

Placebo

Participants received placebo matched TEZ/IVA orally once daily in the morning.

DRUG

Placebo

Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2018-09-26
Completion
2018-10-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • Ireland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03460990 on ClinicalTrials.gov