Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia
The primary objective of this study is to evaluate the blood levels of posaconazole administered orally at three dosage levels to immunocompromised children aged 3 months to less than 18 years with neutropenia or expected neutropenia.
Subjects enrolled will be immunocompromised children 3 months to less than 18 years of age with neutropenia or expected neutropenia. The study drug will be given following chemotherapy given for a diagnosis of leukemia (newly diagnosed or relapsed), myelodysplastic syndrome, advanced stage non-Hodgkinâ??s lymphoma, high risk neuroblastoma, and patients undergoing autologous or allogeneic HSCT during the pre-engraftment period.
Invasive fungal infections (IFIs) are a leading cause of infectious disease morbidity and mortality in immunocompromised patients. Like adults, the pediatric patient population at risk for developing IFIs is similar. Clinical studies in subjects (â?¥ 13 years of age) using posaconazole oral suspension support its use in the treatment of severely Immunocompromised patients, either for prevention or treatment of IFIs. While the data obtained thus far in pediatric subjects suggests posaconazole has been well tolerated and is therapeutic, there is limited information about this population.
06/19/2013 04:02 AM