Fungal Infections Clinical Trial
Official title:
Pharmacokinetics and Safety of Solid Oral Posaconazole (SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05615)
The purpose of this study is to collect pharmacokinetic (PK) information related to how well posaconazole tablet is distributed in the body and to determine the safety of this new formulation. The study consists of a Phase 1B study that includes participants with neutropenia undergoing chemotherapy for acute myelogenous leukemia (AML) or myelodysplasia (MDS) and a Phase 3 study that includes participants who are undergoing chemotherapy for AML or MDS and participants who are recipients of allogeneic hematopoietic stem cell transplant (HSCT).
Participants with a blood disease or cancer that can affect their infection-fighting white
blood cells and those who have undergone a hematopoietic stem cell transplant (HSCT) and are
receiving immunosuppressive therapy and have or are at risk of graft-vs-host disease (GVHD)
are eligible for the study. These blood diseases and their treatments can weaken the immune
system and may put individuals at high risk for a serious fungal infection of their internal
organs or blood (invasive fungal infection). As these infections can be hard to detect early
and can be life-threatening, many physicians believe that individuals diagnosed with these
diseases should receive antifungal therapy to try to lower their risk of getting this type
of infection.
Enrollment into this study will take place in several stages (parts). The determination of
which part a participant will be in is based on which part is open at the site at the time
of enrollment.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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