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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01203527 |
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Date of registration:
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15/09/2010 |
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Primary sponsor: |
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Public title:
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A Study of the Pharmacology of Tamiflu in Pregnancy
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Scientific title:
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A Study of the Pharmacology of Oseltamivir (Tamiflu-Roche) in Pregnancy |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01203527 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort
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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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Steve Caritis, MD |
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Address:
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Telephone:
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412-641-4874 |
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Email:
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scaritis@mail.magee.edu |
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Affiliation:
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Name:
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Raman Venkataramanan, 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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University of Pittsburgh |
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Name:
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Richard Beigi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Name:
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Steve Caritis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Pittsburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Taking or about to start oral oseltamivir for presumed influenza viral infection or
for prophylaxis
2. Able to give informed consent
3. Pregnant female with singleton or multifetal gestation or healthy
non-pregnant female (ancillary study)
Exclusion Criteria:
1. Unable to take medication orally
2. Renal failure - creatinine > 1.5
3. Hct <28
Age minimum:
14 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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H1N1 Influenza Treatment During Pregnancy
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Primary Outcome(s)
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Apparent oral clearance of oseltamivir in singletons
[Time Frame: At the time of treatment]
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Secondary Outcome(s)
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Apparent oral clearance of oseltamivir in twins
[Time Frame: At the time of treatment]
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Apparent renal clearance of oseltamivir carboxylate in non-pregnant women (ancillary study)
[Time Frame: At the time of treatment]
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Concentration of oseltamivir carboxylate and oseltamivir at times 0 and 12h to ascertain steady state status
[Time Frame: At the time of treatment]
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Maternal and cord blood oseltamivir and oseltamivir carboxylate concentrations
[Time Frame: At delivery]
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Maternal side effects -GI upset, pregnancy loss, neuropsychiatric disorder
[Time Frame: At the time of treatment]
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Plasma esterase activity. (ancillary study)
[Time Frame: At the time of treatment]
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Secondary ID(s)
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OPRU Tamiflu
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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