- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01203527
A Study of the Pharmacology of Tamiflu in Pregnancy
A Study of the Pharmacology of Oseltamivir (Tamiflu-Roche) in Pregnancy
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh
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Texas
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Galveston, Texas, Estados Unidos, 77555
- University of Texas Medical Branch
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Unable to take medication orally
- Renal failure - creatinine > 1.5
- Hct <28
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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.
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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.
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Tamiflu use in non-pregnant women
This group will consist of twenty-five non-pregnant healthy female volunteers who are being treated with Oseltamivir.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Apparent oral clearance of oseltamivir in singletons
Periodo de tiempo: At the time of treatment
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At the time of treatment
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Apparent oral clearance of oseltamivir in twins
Periodo de tiempo: At the time of treatment
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At the time of treatment
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Apparent renal clearance of oseltamivir carboxylate in non-pregnant women (ancillary study)
Periodo de tiempo: At the time of treatment
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At the time of treatment
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Concentration of oseltamivir carboxylate and oseltamivir at times 0 and 12h to ascertain steady state status
Periodo de tiempo: At the time of treatment
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At the time of treatment
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Plasma esterase activity. (ancillary study)
Periodo de tiempo: At the time of treatment
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At the time of treatment
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Maternal side effects -GI upset, pregnancy loss, neuropsychiatric disorder
Periodo de tiempo: At the time of treatment
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At the time of treatment
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Maternal and cord blood oseltamivir and oseltamivir carboxylate concentrations
Periodo de tiempo: At delivery
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At delivery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Richard Beigi, MD, University of Pittsburgh
- Investigador principal: Steve Caritis, MD, University of Pittsburgh
- Investigador principal: Raman Venkataramanan, PhD, University of Pittsburgh
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OPRU Tamiflu
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