A Study of Safety and Pharmacokinetics of Repeated Dose o... | NCT00606268

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jan 21, 2008

First Submission Date that Met QC Criteria

Jan 31, 2008

First Posted Date

Feb 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2014

Last Update Posted Date

Aug 21, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is a prospective, multi-center, open-label, repeat-dose pharmacokinetic study that contains two treatment (micafungin 1.0mg/kg and 1.5mg/kg) dose groups. Subjects will be enrolled according to age and stratified by weight to receive either 1.0mg/kg (weight > 25kg) or 1.5mg/kg ( weight < 25kg) micafungin.

Children (4 months to < 2years, 2 to 5 years and 6 to 11 years) and adolescents (12 to 16 years) undergoing HSCT who require antifungal prophylaxis will be enrolled

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Label	Type	Description	Intervention Names
1	Experimental	1.0 mg/kg	Drug: Micafungin
2	Experimental	1.5 mg/kg	Drug: Micafungin

Name	Type	Description	Arm Group Labels	Other Names
Micafungin	Drug	IV	1 2	FK463

Measure	Description	Time Frame
Plasma drug concentration parameters: AUC0-24, Cmax		13-17 Days

Measure	Description	Time Frame
Adverse events, vital signs, ECGs and laboratory test values		Day 1 to End of study

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Months

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90027	United States

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D054714	Echinocandins
D010456	Peptides, Cyclic