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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: |
NCT02310789 |
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Date of registration:
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03/09/2014 |
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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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(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?
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Scientific title:
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(Study: Vertex IIS) A Study To Access the Effects of Ivacaftor on Wild Type CFTR-Open Probability (PO) In The Sweat Gland Secretory Coil |
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Date of first enrolment:
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July 31, 2015 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02310789 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Jeffrey Wine, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Stanford University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy adults without a Cystic Fibrosis (CF) mutation
- Carriers with a known CF mutation
Exclusion Criteria:
1. Documented liver disease
2. Participants should not be taking:
- medicines that are strong CYP3A (Cytochrome P450, family 3, subfamily A)
inducers, such as:
- the antibiotics rifampin and rifabutin;
- seizure medications (phenobarbital, carbamazepine, or phenytoin); and
- the herbal supplement St. John's Wort, substantially decreases exposure of
ivacaftor and may diminish effectiveness.
Age minimum:
18 Years
Age maximum:
N/A
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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Device: Macroduct sweat stimulator
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Drug: Pilocarpine Nitrate 5%
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Drug: Ivacaftor
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Drug: ß-Adrenergic cocktail
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Primary Outcome(s)
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Change in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Dependent Sweat Rate
[Time Frame: Up to 79 days]
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Secondary Outcome(s)
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Change Sweat Chloride Production
[Time Frame: Up to 79 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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