Trial Search Results

A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Astellas Pharma Inc


  • Drug: Micafungin


Phase 1


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

   - 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

   - 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

   - Female subject is pregnant or nursing. Females of childbearing potential must avoid
   becoming pregnant while receiving study drug

Ages Eligible for Study

4 Months - 16 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Laila Craveiro
Not Recruiting