A Study of the Pharmacology of Oseltamivir (Tamiflu) in Pregnancy
NCT ID: NCT00873886
Last Updated: 2015-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2009-04-30
2010-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Oseltamivir (Tamiflu)
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.
Esterase
Blood Draws
Two blood draws (1 teaspoon each) will be performed: once during third trimester of pregnancy and again about eight weeks after delivery.
Interventions
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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.
Blood Draws
Two blood draws (1 teaspoon each) will be performed: once during third trimester of pregnancy and again about eight weeks after delivery.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Richard Beigi
Assistant Professor
Principal Investigators
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Richard H. Beigi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Countries
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References
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Advisory Committee on Immunization Practices; Smith NM, Bresee JS, Shay DK, Uyeki TM, Cox NJ, Strikas RA. Prevention and Control of Influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006 Jul 28;55(RR-10):1-42.
Neuzil KM, Reed GW, Mitchel EF, Simonsen L, Griffin MR. Impact of influenza on acute cardiopulmonary hospitalizations in pregnant women. Am J Epidemiol. 1998 Dec 1;148(11):1094-102. doi: 10.1093/oxfordjournals.aje.a009587.
Irving WL, James DK, Stephenson T, Laing P, Jameson C, Oxford JS, Chakraverty P, Brown DW, Boon AC, Zambon MC. Influenza virus infection in the second and third trimesters of pregnancy: a clinical and seroepidemiological study. BJOG. 2000 Oct;107(10):1282-9. doi: 10.1111/j.1471-0528.2000.tb11621.x.
Cox S, Posner SF, McPheeters M, Jamieson DJ, Kourtis AP, Meikle S. Hospitalizations with respiratory illness among pregnant women during influenza season. Obstet Gynecol. 2006 Jun;107(6):1315-22. doi: 10.1097/01.AOG.0000218702.92005.bb.
Cox S, Posner SF, McPheeters M, Jamieson DJ, Kourtis AP, Meikle S. Influenza and pregnant women: hospitalization burden, United States, 1998-2002. J Womens Health (Larchmt). 2006 Oct;15(8):891-3. doi: 10.1089/jwh.2006.15.891.
Lindsay L, Jackson LA, Savitz DA, Weber DJ, Koch GG, Kong L, Guess HA. Community influenza activity and risk of acute influenza-like illness episodes among healthy unvaccinated pregnant and postpartum women. Am J Epidemiol. 2006 May 1;163(9):838-48. doi: 10.1093/aje/kwj095. Epub 2006 Mar 22.
ACOG Committee on Obstetric Practice. ACOG committee opinion number 305, November 2004. Influenza vaccination and treatment during pregnancy. Obstet Gynecol. 2004 Nov;104(5 Pt 1):1125-6.
Garcia-Sastre A, Whitley RJ. Lessons learned from reconstructing the 1918 influenza pandemic. J Infect Dis. 2006 Nov 1;194 Suppl 2:S127-32. doi: 10.1086/507546.
Webster RG, Govorkova EA. H5N1 influenza--continuing evolution and spread. N Engl J Med. 2006 Nov 23;355(21):2174-7. doi: 10.1056/NEJMp068205. No abstract available.
Ferguson NM, Cummings DA, Cauchemez S, Fraser C, Riley S, Meeyai A, Iamsirithaworn S, Burke DS. Strategies for containing an emerging influenza pandemic in Southeast Asia. Nature. 2005 Sep 8;437(7056):209-14. doi: 10.1038/nature04017. Epub 2005 Aug 3.
Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med. 2005 Sep 29;353(13):1363-73. doi: 10.1056/NEJMra050740. No abstract available.
Dutkowski R, Thakrar B, Froehlich E, Suter P, Oo C, Ward P. Safety and pharmacology of oseltamivir in clinical use. Drug Saf. 2003;26(11):787-801. doi: 10.2165/00002018-200326110-00004.
Health Sciences Authority. Product Safety Alert: new preclinical findings on Oseltamivir. March 2004. (Accessed November 27, 2006 at: http://www.hsa.gov.sg/docs/safetyalert_oseltamivir_March04.pdf.)
Hayden FG, Treanor JJ, Betts RF, Lobo M, Esinhart JD, Hussey EK. Safety and efficacy of the neuraminidase inhibitor GG167 in experimental human influenza. JAMA. 1996 Jan 24-31;275(4):295-9.
Massarella JW, He GZ, Dorr A, Nieforth K, Ward P, Brown A. The pharmacokinetics and tolerability of the oral neuraminidase inhibitor oseltamivir (Ro 64-0796/GS4104) in healthy adult and elderly volunteers. J Clin Pharmacol. 2000 Aug;40(8):836-43. doi: 10.1177/00912700022009567.
Ward P, Small I, Smith J, Suter P, Dutkowski R. Oseltamivir (Tamiflu) and its potential for use in the event of an influenza pandemic. J Antimicrob Chemother. 2005 Feb;55 Suppl 1:i5-i21. doi: 10.1093/jac/dki018.
Other Identifiers
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IRB #PRO07080362
Identifier Type: -
Identifier Source: org_study_id
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