A Study of the Pharmacology of Tamiflu in Pregnancy

Completed

Conditions studied: H1N1 Influenza Treatment During Pregnancy

In brief

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.

Key facts

Study ID

NCT01203527

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

63

Starts

2007-03-01

Expected to finish

2012-10-01

Last updated by the study team

2013-10-09

Who can join

Age: 14 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Taking or about to start oral oseltamivir for presumed influenza viral infection or for prophylaxis
• Able to give informed consent
• Pregnant female with singleton or multifetal gestation or healthy non-pregnant female (ancillary study)

You may not qualify if…

• Unable to take medication orally
• Renal failure - creatinine > 1.5
• Hct <28

Where it is running

• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Medical Branch — Galveston, Texas, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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