Status:
WITHDRAWN
A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy
Influenza
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The primary research question of this study is: Does the pharmacokinetics of oseltamivir after a single oral dose differ between the pregnant and non-pregnant women?
Detailed Description
With the pending threat of pandemic avian influenza, the disproportionate morbidity and mortality documented in previous 20th century pandemics among pregnant women, and the lack of any data for use o...
Eligibility Criteria
Inclusion
- For Oseltamivir (Tamiflu) arm:
- Singleton gestation prior to 24 0/7 weeks gestation
- Planning to undergo a termination procedure for the incident pregnancy
- Willingness to take the single-dose medication and to follow study procedures
- Able to undergo informed consent.
- For Esterase arm:
- Singleton gestation greater than 32 completed weeks and less than 40 completed weeks of gestation
- Absence of severe pregnancy complication that could affect body volume and or metabolism (i.e., preeclampsia, renal dysfunction, hepatic dysfunction \[defined as serum creatinine clearance of \< 30 ml/min or a known ALT/AST\> 2x facility normal value\], etc.)
- Willingness to follow study procedures
- Able to undergo informed consent
- The use of medications that may affect renal metabolism is not a contraindication to participation since these subjects are only undergoing PK sampling.
Exclusion
- For Oseltamivir (Tamiflu) arm:
- Known current in utero fetal death
- Significant medical history and/or medication use as determined by the investigator that has the potential to affect results of the study or put the patient at risk from the single-dosing
- Known hypersensitivity to the components of the study drug
- Known hepatic or renal dysfunction (defined as serum creatinine clearance of \< 30 ml/min or a known ALT/AST\> 2x facility normal value)
- Chronic use of street drugs (obtained via subject interview and/or medical history)
- Participation in any other concurrent interventional study.
- We will ask if they have a history of depression in the past requiring treatment or if they are currently actively depressed. If either of these questions yields a positive response, we will not consider the patient eligible and will not enroll the subject.
- For Esterase arm:
- Known current in utero fetal death
- Significant medical history as determined by the investigator to potentially affect results of the study
- Chronic use of street drugs (obtained via subject interview and/or medical history
- Participation in any other concurrent interventional study.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00873886
Start Date
April 1 2009
End Date
September 1 2010
Last Update
September 29 2015
Active Locations (1)
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1
Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213