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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03633526 |
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Date of registration:
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27/07/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
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Scientific title:
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A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age |
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Date of first enrolment:
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August 3, 2018 |
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Target sample size:
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18 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03633526 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
11 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: VX-659/TEZ/IVA
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Drug: IVA
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Primary Outcome(s)
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Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of VX-659, TEZ, and IVA
[Time Frame: Day 1 and Day 15]
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Maximum Observed Concentration (Cmax) of VX-659, TEZ, and IVA
[Time Frame: Day 1 and Day 15]
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Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, and IVA
[Time Frame: Day 8 and Day 15]
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Secondary Outcome(s)
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Observed Pre-Dose Concentration (Ctrough) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA)
[Time Frame: Day 8 and Day 15]
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Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA)
[Time Frame: Day 1 and Day 15]
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Maximum Observed Concentration (Cmax) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA)
[Time Frame: Day 1 and Day 15]
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 6 weeks)]
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Secondary ID(s)
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VX18-659-106
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2018-001711-67
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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