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PregnancyPhase 1NCT00873886

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

A Phase 1 study testing Oseltamivir (Tamiflu) and Blood Draws in people with Pregnancy and Influenza, run by University of Pittsburgh at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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? Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Influenza
What is being tested?
Oseltamivir (Tamiflu) and Blood Draws
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2009to Sep 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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.

Who cannot join

  • 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)
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Magee-Womens Hospital of University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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?

Read the detailed description

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.

Conditions
Pregnancy, Influenza
Being tested
Oseltamivir (Tamiflu), Blood Draws
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oseltamivir (Tamiflu)Drug

    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.

    1. Subject will take 75 mg of oseltamivir pill by mouth
    2. Multiple blood draws (1 teaspoon each) over the next 48 hours after taking oseltamivir. Urine samples also will be collected.

  • Blood DrawsProcedure or surgery

    Two blood draws (1 teaspoon each) will be performed: once during third trimester of pregnancy and again about eight weeks after delivery.

Study groups in NCT00873886
Study groupRoleWhat they receive
Oseltamivir (Tamiflu)ExperimentalNot described
Receives: Drug: Oseltamivir (Tamiflu)
EsteraseOtherNot described
Receives: Procedure: Blood Draws

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester.

Secondary outcomes (4)

  1. Non-compartmental model analysis for Cmax, Tmax, Cl/F, Clr,V/F, MRT and t ½.

    Measured: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester.

  2. Plasma concentrations of oseltamivir after single-dosing.

    Measured: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester.

  3. Evaluation of carboxy-esterase levels and activity in all trimesters of pregnancy with comparison to the post-partum internal controls.

    Measured: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester.

  4. Tolerance (side effect profile) of single-dose oseltamivir in pregnancy.

    Measured: Less than 9 weeks for subjects planning termination; up to 5 months for subjects enrolled during their 3rd trimester.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionSep 2010 (estimated)
  4. Study completionSep 2010 (estimated)

Why it stopped: We will focus on other Tamiflu research studies. No subjects were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00873886
Sponsor's protocol ID
IRB #PRO07080362
Other IDs
5U10HD047905-02
Status last verified
Sep 2015
First submitted
1 Apr 2009
Last updated
29 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16874296

  • 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.

    PubMed 9850132

  • 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.

    PubMed 11028582

  • 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.

    PubMed 16738158

  • 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.

    PubMed 17087611

  • 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.

    PubMed 16554352

  • 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.

    PubMed 15516422

  • 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.

    PubMed 17163385

  • 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.

    PubMed 17124014

  • 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.

    PubMed 16079797

  • Moscona A. Neuraminidase inhibitors for influenza. N Engl J Med. 2005 Sep 29;353(13):1363-73. doi: 10.1056/NEJMra050740. No abstract available.

    PubMed 16192481

  • 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.

    PubMed 12908848

  • 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.

    PubMed 8544269

  • 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.

    PubMed 10934667

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oseltamivir (Tamiflu) and Blood Draws in people with Pregnancy and Influenza, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00873886, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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