©2024 Stanford Medicine
A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant
Not Recruiting
Trial ID: NCT00606268
Purpose
The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal
prophylaxis in children and adolescents undergoing HSCT
Official Title
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin as an Antifungal Prophylaxis in Children and Adolescents Undergoing Hematopoietic Stem Cell Transplant
Eligibility
Inclusion Criteria:
- Institutional Review Board (IRB)-approved written informed Consent / Assent (as
applicable) and HIPAA Authorization must be obtained from the subject (as able) and
/or subject's parent/legally authorized representative prior to any study-related
procedures
- Subject has sufficient venous access to permit administration of study drug, collect
pharmacokinetic samples and monitor laboratory safety variables
- Female subject of childbearing potential must have a negative pregnancy test within 72
hours prior to the first dose of study drug, and if sexually active agree method of
birth control per Investigator judgment for the duration of the study
- Subject (when able) and /or subjects parent/legally authorized representative agree to
comply with the study requirements and with the concomitant medication restrictions
- Subject plans to undergo a HSCT
Exclusion Criteria:
- Subject has evidence of significant liver disease as defined by aspartate transamine
(AST/SGOT), alanine transaminases (ALT/SGPT) 10 times the upper limit of normal (ULN)
and total bilirubin or alkaline phosphatase > 5 times the ULN
- Subject has concomitant medical condition that in the opinion of the Investigator and
/or medical monitor precludes enrollment into the study
- Subject with evidence of an active systemic or disseminated fungal infection prior to
enrollment
- Subject has a history of anaphylaxis, hypersensitivity, or any serious reactions to
the echinocandin class of antifungals
- Subject had received treatment with an echinocandin within one week prior to first
dose of study drug
- Subject status is unstable and subject is unlikely to complete required study
procedures
- Female subject is pregnant or nursing. Females of childbearing potential must avoid
becoming pregnant while receiving study drug
Intervention(s):
drug: Micafungin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Laila Craveiro
6507249179