A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy

Withdrawn before enrolling · Phase 1

Conditions studied: Pregnancy, Influenza

In brief

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?

Key facts

Study ID

NCT00873886

Run by

University of Pittsburgh

People needed

0

Starts

2009-04-01

Expected to finish

2010-09-01

Last updated by the study team

2015-09-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Magee-Womens Hospital of University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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