H1N1 Influenza Treatment During PregnancyNCT01203527
A Study of the Pharmacology of Tamiflu in Pregnancy
An observational study of H1N1 Influenza Treatment During Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- H1N1 Influenza Treatment During Pregnancy
- How many people
- 63 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2007to Oct 2012
- Phase
- Observational
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant and non-pregnant women
Who may be able to join
- 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)
Who cannot join
- Unable to take medication orally
- Renal failure - creatinine > 1.5
- Hct <28
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Medical Branch
Galveston, Texas, 77555
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Washington
Seattle, Washington, 98195
About this study
Official title: 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.
Read the detailed description
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:
- collect biological fluids (plasma and urine) to further characterize the pharmacology of the drug;
- collect a check swab for DNA to allow study of the impact of single nucleotide polymorphisms on drug handing and disease expression;
- develop an assay or partner with others to develop an assay for oseltamivir and the primary metabolite, oseltamivir carboxylate;
- 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;
- assess the impact of fetal number on the drug's pharmacokinetics;
- 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
- 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.
- Keywords
- H1N1 influenza, Swine flu, Oseltamivir, Tamiflu, Pregnancy
- Medical subject headings
- Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent oral clearance of oseltamivir in singletons
Measured: At the time of treatment
Secondary outcomes (6)
Apparent oral clearance of oseltamivir in twins
Measured: At the time of treatment
Apparent renal clearance of oseltamivir carboxylate in non-pregnant women (ancillary study)
Measured: At the time of treatment
Concentration of oseltamivir carboxylate and oseltamivir at times 0 and 12h to ascertain steady state status
Measured: At the time of treatment
Plasma esterase activity. (ancillary study)
Measured: At the time of treatment
Maternal side effects -GI upset, pregnancy loss, neuropsychiatric disorder
Measured: At the time of treatment
Maternal and cord blood oseltamivir and oseltamivir carboxylate concentrations
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startMar 2007
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H1N1 Influenza Treatment During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Richard Beigi, MD, Principal investigator, University of PittsburghSteve Caritis, MD, Principal investigator, University of PittsburghRaman Venkataramanan, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203527
- Sponsor's protocol ID
- OPRU Tamiflu
- Status last verified
- Aug 2013
- First submitted
- 15 Sep 2010
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Pharmacology of Oseltamivir (Tamiflu-Roche) in Pregnancy
- ClinicalTrials.gov ID
- NCT01203527
- Acronym / sponsor ID
- OPRU Tamiflu
- Keywords
- H1N1 influenza, Swine flu, Oseltamivir, Tamiflu, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- collect biological fluids (plasma and urine) to further characterize the pharmacology of the drug;
- collect a check swab for DNA to allow study of the impact of single nucleotide polymorphisms on drug handing and disease expression;
- develop an assay or partner with others to develop an assay for oseltamivir and the primary metabolite, oseltamivir carboxylate;
- 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;
- assess the impact of fetal number on the drug's pharmacokinetics;
- 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
- 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.
Study design
- Observational model
- Cohort
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant and non-pregnant women
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Unable to take medication orally
- Renal failure - creatinine > 1.5
- Hct <28
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apparent oral clearance of oseltamivir in singletons
Time frame: At the time of treatment
6 secondary outcomes
Apparent oral clearance of oseltamivir in twins
Time frame: At the time of treatment
Apparent renal clearance of oseltamivir carboxylate in non-pregnant women (ancillary study)
Time frame: At the time of treatment
Concentration of oseltamivir carboxylate and oseltamivir at times 0 and 12h to ascertain steady state status
Time frame: At the time of treatment
Plasma esterase activity. (ancillary study)
Time frame: At the time of treatment
Maternal side effects -GI upset, pregnancy loss, neuropsychiatric disorder
Time frame: At the time of treatment
Maternal and cord blood oseltamivir and oseltamivir carboxylate concentrations
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Beigi, MD principal investigator
University of Pittsburgh
Steve Caritis, MD principal investigator
University of Pittsburgh
Raman Venkataramanan, PhD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of H1N1 Influenza Treatment During Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Apparent oral clearance of oseltamivir in singletons (time frame: At the time of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2013.