NCT01135589

Brief Summary

This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
145

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2010

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

September 28, 2010

Status Verified

June 1, 2010

Enrollment Period

2.1 years

First QC Date

May 25, 2010

Last Update Submit

September 27, 2010

Conditions

NeutropeniaHematopoietic Stem Cell TransplantationInvasive Fungal Disease

Keywords

pediatricadolescentmicafungin

Outcome Measures

Primary Outcomes (1)

  • Absence rate of IFDs assessed by physical examination and serum galactomannan test

    during micafungin prophylaxis therapy and during 4 weeks after stopping of micafungin prophylaxis

Secondary Outcomes (2)

  • Survival rate

    at day 100

  • Safety assessed by lab-test and adverse events

    during micafungin prophylaxis therapy

Study Arms (1)

HSCT

EXPERIMENTAL
Drug: Micafungin

Interventions

MicafunginDRUG

i.v.

Also known as: FK463, Fungard
HSCT

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients will receive allogeneic hematopoietic stem cell transplantation

You may not qualify if:

  • Aspartate transaminase or alanine transaminase level \> 5 times UNL
  • Bilirubin \> 2. 5 times UNL
  • History of allergy, sensitivity, or any serious reaction to an echinocandin
  • Invasive fungal disease at the time of enrolment
  • Systemic antifungal therapy within 72 hrs before administration of the first dose of study drug
  • Positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Busan, South Korea

RECRUITING

Unknown Facility

Daegu, South Korea

RECRUITING

Unknown Facility

Daejeon, South Korea

RECRUITING

Unknown Facility

Goyang, South Korea

RECRUITING

Unknown Facility

Hwasun, South Korea

RECRUITING

Unknown Facility

Seoul, South Korea

RECRUITING

Unknown Facility

Suwon, South Korea

RECRUITING

MeSH Terms

Conditions

NeutropeniaInvasive Fungal Infections

Interventions

Micafungin

Condition Hierarchy (Ancestors)

AgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte DisordersMycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, Cyclic

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Central Study Contacts

Clinical Development Administration Dept.

CONTACT

clinicaltrials_info@jp.astellas.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2010

First Posted

June 3, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 28, 2010

Record last verified: 2010-06

Locations

KR(7)