A Study of the Pharmacology of Tamiflu in Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01203527
First received: September 15, 2010
Last updated: October 8, 2013
Last verified: August 2013

September 15, 2010
October 8, 2013
March 2007
October 2012   (final data collection date for primary outcome measure)
Apparent oral clearance of oseltamivir in singletons [ Time Frame: At the time of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01203527 on ClinicalTrials.gov Archive Site
  • Apparent oral clearance of oseltamivir in twins [ Time Frame: At the time of treatment ] [ Designated as safety issue: No ]
  • Apparent renal clearance of oseltamivir carboxylate in non-pregnant women (ancillary study) [ Time Frame: At the time of treatment ] [ Designated as safety issue: No ]
  • Concentration of oseltamivir carboxylate and oseltamivir at times 0 and 12h to ascertain steady state status [ Time Frame: At the time of treatment ] [ Designated as safety issue: No ]
  • Plasma esterase activity. (ancillary study) [ Time Frame: At the time of treatment ] [ Designated as safety issue: No ]
  • Maternal side effects -GI upset, pregnancy loss, neuropsychiatric disorder [ Time Frame: At the time of treatment ] [ Designated as safety issue: No ]
  • Maternal and cord blood oseltamivir and oseltamivir carboxylate concentrations [ Time Frame: At delivery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Pharmacology of Tamiflu in Pregnancy
A Study of the Pharmacology of Oseltamivir (Tamiflu-Roche) in Pregnancy

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.

The emergence of the novel H1N1 influenza virus has raised concern among public health officials and the public alike. Although initial reports suggested that the risk of serious disease or death was less than initially feared, continued experience suggests that the disease will have a major impact on the public's health. To address this urgent public health challenge, the centers of the Obstetric-Fetal Pharmacology Research Units Network (OPRU) will recruit a total of 75 pregnant women (25 per trimester with singletons pregnancies) who are receiving oseltamivir for supposed influenza infection. When possible, we will recruit women with twin gestation to determine if fetal number affects the drugs pharmacokinetics. We do not anticipated a significant number of multi-fetal gestations (< 10) but even limited data might prove useful in this population given the tremendous change in renal drug clearance that is normally seen in this group of women. An additional 25 healthy non-pregnant women will be studied to define pregnancy- related changes in the PK of oseltamivir and the carboxylate.

We will study each woman once during therapy, performing steady state pharmacokinetic analyses. This study will be performed after 3 days of oral therapy to optimize the possibility that steady state concentrations have been achieved.

We will:

  1. collect biological fluids (plasma and urine) to further characterize the pharmacology of the drug;
  2. collect a check swab for DNA to allow study of the impact of single nucleotide polymorphisms on drug handing and disease expression;
  3. develop an assay or partner with others to develop an assay for oseltamivir and the primary metabolite, oseltamivir carboxylate;
  4. compare the pharmacokinetics of oseltamivir and its metabolite in each trimester of pregnancy to evaluate whether gestational age has an impact on the drug's pharmacokinetics;
  5. assess the impact of fetal number on the drug's pharmacokinetics;
  6. ask all participants about GI tolerance to the drug and any side effects they may be experiencing, especially related to mood and psychiatric well being; and
  7. on all pregnant subjects studied, when possible, we will obtain at delivery maternal and umbilical cord blood to evaluate placental transport especially in those who deliver proximate (within 3 days) to drug treatment.
Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

Blood and urine

Non-Probability Sample

Pregnant and non-pregnant women

H1N1 Influenza Treatment During Pregnancy
Not Provided
  • Tamiflu use during first trimester
    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.
  • Tamiflu use during second trimester
    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.
  • Tamiflu use during third trimester
    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.
  • Tamiflu use in non-pregnant women
    This group will consist of twenty-five non-pregnant healthy female volunteers who are being treated with Oseltamivir.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unable to take medication orally
  2. Renal failure - creatinine > 1.5
  3. Hct <28
Female
14 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01203527
OPRU Tamiflu
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Richard Beigi, MD University of Pittsburgh
Principal Investigator: Steve Caritis, MD University of Pittsburgh
Principal Investigator: Raman Venkataramanan, PhD University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP