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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02730208
Registration number
NCT02730208
Ethics application status
Date submitted
31/03/2016
Date registered
6/04/2016
Date last updated
23/10/2019
Titles & IDs
Public title
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
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Scientific title
A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
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Secondary ID [1]
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VX15-661-112
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tezacaftor/Ivacaftor
Treatment: Drugs - Ivacaftor
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo
Experimental: TEZ/IVA - Participants received TEZ 100 milligram (mg)/IVA 150 mg fixed dose combination tablet orally once daily in the morning and IVA 150 mg tablet orally once daily in the evening for 72 weeks.
Placebo Comparator: Placebo - Participants received placebo matched to TEZ/IVA fixed dose combination tablet orally once daily in the morning and placebo matched to IVA tablet orally once daily in the evening for 72 weeks.
Treatment: Drugs: Tezacaftor/Ivacaftor
TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.
Treatment: Drugs: Ivacaftor
IVA 150 mg tablet.
Treatment: Drugs: Placebo
Placebo matched to TEZ/IVA fixed-dose combination tablet.
Treatment: Drugs: Placebo
Placebo matched to IVA tablet.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absolute Change in Total Brody/CF-CT Score
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Assessment method [1]
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The exploratory Brody/CF-CT score semi-quantitatively scores the degree of structural lung disease as shown on CT in participants with CF. The score ranges from a minimum of 0 to a maximum of 219 with higher scores indicating more severe structural lung disease.
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Timepoint [1]
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From Baseline at Week 72
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Secondary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Timepoint [1]
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Day 1 up to Week 76
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Eligibility
Key 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
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
therapy (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 the
contraception requirements.
- Any contraindication to undergoing chest imaging, as per the site's institutional
guidelines
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2018
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Sample size
Target
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Accrual to date
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Final
41
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Chermside
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Recruitment hospital [2]
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- Melbourne
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Recruitment hospital [3]
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- Nedlands
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Recruitment hospital [4]
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- New Lambton Heights
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Recruitment hospital [5]
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- Parkville SIC
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Recruitment hospital [6]
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- Randwick
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Recruitment hospital [7]
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- South Brisbane
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Recruitment hospital [8]
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- Subiaco
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Recruitment hospital [9]
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- Westmead
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Recruitment postcode(s) [1]
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- Chermside
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment postcode(s) [3]
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- Nedlands
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Recruitment postcode(s) [4]
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- New Lambton Heights
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Recruitment postcode(s) [5]
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- Parkville SIC
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Recruitment postcode(s) [6]
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- Randwick
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Recruitment postcode(s) [7]
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- South Brisbane
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Recruitment postcode(s) [8]
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- Subiaco
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Recruitment postcode(s) [9]
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- Westmead
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Vertex Pharmaceuticals Incorporated
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02730208
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02730208
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