Milk-only Lactation Study for Patients on Eltrombopag

Autores
Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2013

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This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing mothers taking marketed eltrombopag (PROMACTA®). Up to 10 subjects (mother-infant pairs) at as many as 10 study centers in the US will be enrolled. Nursing mothers who are registered with the PROMACTA Pregnancy Registry will be offered the option to participate in this trial if they continue to take commercial eltrombopag post-delivery and decide to breastfeed their infant. Information will be collected in a diary. Breast milk samples will be collected before and after infant feedings for a 24 hour period after eltrombopag dosing to evaluate the eltrombopag concentrations in the breast milk. Mothers will also be given the option to have a pharmacokinetic (PK) blood sample collected from the infant.
Epistemonikos ID: 0767e44fb889ce44b93b85c1a0381f0554b042f1
First added on: May 05, 2024