A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy
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|ClinicalTrials.gov Identifier: NCT00873886|
Recruitment Status : Withdrawn (We will focus on other Tamiflu research studies. No subjects were enrolled.)
First Posted : April 2, 2009
Last Update Posted : September 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Influenza||Drug: Oseltamivir (Tamiflu) Procedure: Blood Draws||Phase 1|
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 of these vital antiviral drugs in pregnancy, study of the pharmacology of oseltamivir in pregnancy is imperative. If and when the next pandemic occurs, a better understanding of this drug's safety and pharmacologic profiles for use in pregnancy is critical given the fact that it will be used in this vulnerable patient population.
This is a pilot study of the use of oseltamivir in pregnancy. This data will be combined with data from the parallel Pediatric Pharmacology Research Unit (PPRU) studies to put together a portfolio for use in understudied populations. This will allow for a re-thinking of the current status and potentially allow for small trials to be performed with patients who are suffering from influenza in pregnancy, to assess efficacy. The relevance with the pandemic strain and its corresponding Minimum Inhibitory Concentration (MIC) may have direct implications for dosing in pregnancy if lower levels of drug are documented. In addition, depending on the findings from the esterase component of the investigation, future investigation into mechanistic bases for changes in enzyme activity are possible.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||September 2010|
|Experimental: Oseltamivir (Tamiflu)||
Drug: Oseltamivir (Tamiflu)
The following procedures will be performed on two occasions: once at least three days prior to the scheduled pregnancy termination procedure and again about eight weeks after the termination procedure.
A) Subject will take 75 mg of oseltamivir pill by mouth
B) Multiple blood draws (1 teaspoon each) over the next 48 hours after taking oseltamivir. Urine samples also will be collected.
Procedure: Blood Draws
Two blood draws (1 teaspoon each) will be performed: once during third trimester of pregnancy and again about eight weeks after delivery.
- Change in the area under the concentration vs. time curve (AUC 0-7 d) in the first and second trimesters of pregnancy with comparisons to the post-termination non-pregnant follow-up data on these enrollees and historical non-pregnant data. [ Time Frame: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester. ]
- Non-compartmental model analysis for Cmax, Tmax, Cl/F, Clr,V/F, MRT and t ½. [ Time Frame: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester. ]
- Plasma concentrations of oseltamivir after single-dosing. [ Time Frame: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester. ]
- Evaluation of carboxy-esterase levels and activity in all trimesters of pregnancy with comparison to the post-partum internal controls. [ Time Frame: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester. ]
- Tolerance (side effect profile) of single-dose oseltamivir in pregnancy. [ Time Frame: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873886
|United States, Pennsylvania|
|Magee-Womens Hospital of University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Richard H. Beigi, MD||University of Pittsburgh|