Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT02452034
Eligibility Criteria:
Inclusion Criteria:
* Have documented or anticipated neutropenia expected to last for at least 7 days, following treatment in at least one of the following clinical situations: acute leukemia, myelodysplasia, severe aplastic anemia, recipients of Autologous Hematopoietic Stem Cell Transplant (HSCT), high risk neuroblastoma, advanced stage non-Hodgkin's lymphoma, hemophagocytic lymphohistiocytosis
* Have a central line in place prior to IV study therapy
* Participants of reproductive potential agree to remain abstinent, or use a medically accepted method of birth control
Exclusion Criteria:
* Has a proven or probable invasive fungal infection
* Has received any formulation of POS within prior 10 days
* Is receiving any prohibited drugs
* 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; b) Calculated creatinine clearance \<30 mL/min.
* Has QTc (QT interval corrected for rate) prolongation defined as: a) Symptomatic QTc prolongation \>450 msec (males) or \>470 msec (females) OR b) Any QTc prolongation of \>500 msec
* Is pregnant, intends to become pregnant during study, or is breastfeeding
* Has a history of anaphylaxis attributed to the azole class of antifungal agents
* Is not expected to receive a minimum of 10 days of POS IV solution
* Has participated in any Phase 1 Investigational New Drug (IND) study within prior 30 days or expects to do so within the following 60 days
* Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT02452034
Study Brief:
Protocol Section:
NCT02452034