NCT01203527|Completed
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Sponsor study identifier
observational
63
1 country
4
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)The purpose of this study is to determine the pharmacokinetics (PK) of the anti-flu medication, Tamiflu during pregnancy and to determine to what extent pregnancy may affect the currently recommended dosage of this medication.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 15, 2010
Actual (reported)September 16, 2010
Actual (reported)October 2012
Actual (reported)October 2012
Actual (reported)Apparent oral clearance of oseltamivir in singletons
At the time of treatment
Apparent oral clearance of oseltamivir in twins
At the time of treatment
Apparent renal clearance of oseltamivir carboxylate in non-pregnant women (ancillary study)
At the time of treatment
Concentration of oseltamivir carboxylate and oseltamivir at times 0 and 12h to ascertain steady state status
At the time of treatment
Plasma esterase activity. (ancillary study)
At the time of treatment
Maternal side effects -GI upset, pregnancy loss, neuropsychiatric disorder
At the time of treatment
This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the first trimester of their pregnancy.
This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the second trimester of their pregnancy.
This group will consist of twenty-five pregnant women who are being treated with Oseltamivir for clinical indications during the first trimester of their pregnancy.
This group will consist of twenty-five non-pregnant healthy female volunteers who are being treated with Oseltamivir.
Pregnant and non-pregnant women
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
University of Washington
Seattle, Washington, 98195, United States
Blood and urine
Richard Beigi, MD
University of Pittsburgh
Steve Caritis, MD
University of Pittsburgh
Raman Venkataramanan, PhD
University of Pittsburgh
63 participants (actual enrollment reported by the registry).
First Submitted
September 15, 2010
First Posted
September 16, 2010
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
October 9, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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