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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00608335
Other study ID # 9463-CL-2101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 14, 2007
Est. completion date September 8, 2011

Study information

Verified date July 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children with fungal infections will be divided into two groups by weight. Children weighing < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing > 25 kg.


Description:

This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.

At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date September 8, 2011
Est. primary completion date September 8, 2011
Accepts healthy volunteers No
Gender All
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria:

1. Subject is 2 to 16 years inclusive

2. Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis

3. Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion Criteria:

1. Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase > 5 times the upper limit of normal (ULN)

2. Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study

3. Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals

4. Subject has received treatment with an echinocandin within one week prior to first dosing

5. Subject status is unstable and subject is unlikely to complete all study required procedures

Study Design


Intervention

Drug:
Micafungin
IV

Locations

Country Name City State
South Africa Benmed Park Clinic Benoni
South Africa Grootte Schuur Hospital Cape Town
South Africa GCT -Sunnyside Medi-clinic Lynn East
South Africa St. Mary's Hospital Mariannhill
South Africa Jubilee Hospital Temba
South Africa 2 Military Hospital Wynberg
United States University of Texas Southwestern Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Texas Children's Hospital Houston Texas
United States Children's Mercy Hospital Kansas City Missouri
United States University of California Los Angeles Medical Center Los Angeles California
United States Children's Hospital of Orange County Orange California
United States Oregon Health and Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary PK parameters (AUCtau, Tmax, and Cmax) 10 - 14 Days
Secondary Adverse events Day 1 to End of Study
Secondary Vital signs Day 1 to End of Study
Secondary Hematology and chemistry laboratory tests Day 1 to End of Study
Secondary 12-lead ECGs and Physical examination Day 1 to End of Study
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