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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01716234
Eligibility Criteria:
Inclusion Criteria:
* Documented or anticipated neutropenia expected to last at least 7 days and only in the following clinical situations: acute leukemia; myelodysplasia; severe aplastic anemia; autologous hematopoietic stem cell transplantation (HSCT) recipients; high risk neuroblastoma; advanced stage non-Hodgkin's lymphoma; recipients of allogeneic HSCT during the pre-engraftment (neutropenia) period
* Participants of child-bearing potential must use a medically accepted method of
contraception throughout the study and for at least 30 days after stopping study medication, unless they are surgically or medically sterile or agree to remain abstinent.
Exclusion Criteria:
* Proven invasive fungal infection (IFI) before study entry
* Severe nausea and/or vomiting at screening
* Received posaconazole within 10 days before screening
* Unable to receive study drug by mouth or via an intestinal (enteral) tube
* Females who are pregnant, intend to become pregnant during the study, or are breastfeeding
* History of anaphylaxis attributed to the azole class of antifungal agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
17 Years
Study:
NCT01716234
Study Brief:
Protocol Section:
NCT01716234