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Trial record 9 of 14 for:    VX-661

A Phase 3 Study of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Vertex Pharmaceuticals Incorporated
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT02412111
First received: April 3, 2015
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.

Condition Intervention Phase
Cystic Fibrosis
Drug: ivacaftor
Drug: VX-661
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Absolute change in percent predicted forced expiratory volume in 1 second (FEV1) [ Time Frame: from baseline through Week 8 ]

Secondary Outcome Measures:
  • Relative change in percent predicted FEV1 [ Time Frame: from baseline through Week 8 ]
  • Absolute change in sweat chloride [ Time Frame: from baseline through Week 8 ]
  • Absolute change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score [ Time Frame: from baseline through Week 8 ]
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening through 4 weeks after receiving last dose ]
  • PK parameters of VX-661, M1-661, ivacaftor, and M1-ivacaftor including area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) as determined by population PK analysis [ Time Frame: From Week -2 through Week 2 ]

Estimated Enrollment: 200
Study Start Date: June 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VX-661/ ivacaftor

AM: VX-661 100-mg/ivacaftor 150-mg fixed-dose tablet ivacaftor matching placebo tablet oral

PM: ivacaftor 150-mg tablet oral

Drug: ivacaftor
Other Name: VX-770
Drug: VX-661 Drug: Placebo
Active Comparator: ivacaftor

AM: VX-661/ivacaftor matching placebo tablet ivacaftor 150-mg tablet oral

PM: ivacaftor 150-mg tablet oral

Drug: ivacaftor
Other Name: VX-770
Drug: Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
  • FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
  • Stable CF disease as judged by the investigator.

Exclusion Criteria:

  • History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
  • Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
  • Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02412111

Contacts
Contact: Medical Information 617-341-6777 medicalinfo@vrtx.com

  Show 64 Study Locations
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
  More Information

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT02412111     History of Changes
Other Study ID Numbers: VX14-661-109
Study First Received: April 3, 2015
Last Updated: February 23, 2017

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 27, 2017