A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects with Neutropenia - Pediatric PK Study (POS IV and PFS)

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prophylaxis of invasive fungal infections in immunocompromised pediatric subjects with neutropenia or expected neutropenia.
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 83
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

June 15, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\)Be a child or adolescent of either sex and of any race, 2 to 17 years of age at the time of screening.
•2\)Have a parent/guardian or legally authorized representative who is willing to give written informed consent. Assent will be obtained from minors according to institutional practices. The guardian/subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
•3\)Have documented or anticipated neutropenia (ANC \< 500/mm3 \[0\.5 x 109 /L]) expected to last for at least 7 days following start of study treatment in at least one of the following clinical situations:
•a.Acute leukemia,
•b.Myelodysplasia,
•c.Severe aplastic anemia,
•d.Recipients of Autologous HSCT,
•e.High risk neuroblastoma,
•f.Advanced stage non\-Hodgkin´s lymphoma (NHL),
•g.Recipients of allogeneic HSCT during the pre\-engraftment (neutropenic) period

•The subject must be excluded from participating in the trial if the subject:
•1\)Has a proven or probable IFI, as defined by the 2008 European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) consensus group criteria, at the time of screening.
•2\)Has received POS (any formulation) within the past 10 days prior to screening.
•3\)Is receiving prohibited drugs (has not met the required washout periods as listed in Section 5\.5\.1\) at the time of randomization or is expected to receive such prohibited medications during the course of study therapy.
•4\)Has laboratory results that are outside of normal limits at screening, as follows:
•a)Moderate or severe liver dysfunction, as defined as:
•\-Aspartate aminotransferase (AST) \> 5 times the upper limit of normal (ULN), OR
•\-Alanine aminotransferase (ALT) \> 5 times the ULN, OR
•\-Serum total bilirubin \>2\.5 times the ULN, OR
•\-AST or ALT \> 3 times ULN with total bilirubin \> 2 times ULN,