A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Last updated: October 22, 2019
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

2

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT02730208
VX15-661-112
  • Ages > 12
  • All Genders

Study Summary

The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Homozygous for the F508del CFTR mutation

  • Confirmed diagnosis of CF

  • Percent predicted forced expiratory volume (ppFEV1) ≥70% of predicted normal for age,sex, and height during screening.

  • Stable CF disease as judged by the investigator

Exclusion

Exclusion Criteria:

  • History of any comorbidity that, in the opinion of the investigator, might confoundthe results of the study or pose an additional risk in administering study drug to thesubject.

  • An acute upper or lower respiratory infection, pulmonary exacerbation, or changes intherapy (including antibiotics) for pulmonary disease within 28 days before Day 1 (first dose of study drug)

  • Pregnant or nursing females.

  • Sexually active subjects of reproductive potential who are not willing to follow thecontraception requirements.

  • Any contraindication to undergoing chest imaging, as per the site's institutionalguidelines

Study Design

Total Participants: 41
Study Start date:
September 01, 2016
Estimated Completion Date:
July 31, 2018

Connect with a study center

  • Chermside,
    Australia

    Site Not Available

  • Melbourne,
    Australia

    Site Not Available

  • Nedlands,
    Australia

    Site Not Available

  • New Lambton Heights,
    Australia

    Site Not Available

  • Parkville SIC,
    Australia

    Site Not Available

  • Randwick,
    Australia

    Site Not Available

  • South Brisbane,
    Australia

    Site Not Available

  • Subiaco,
    Australia

    Site Not Available

  • Westmead,
    Australia

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.