NCT00794703

Brief Summary

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

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

November 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 28, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

November 19, 2008

Last Update Submit

March 25, 2016

Conditions

FungemiaFungal Infections

Keywords

Antifungalmicafunginitraconazole

Outcome Measures

Primary Outcomes (1)

  • Treatment success rate (fungal breakthrough rate)

    At the end of the study

Secondary Outcomes (4)

  • Incidence of proven or probable invasive fungal infection

    Throughout the study period

  • The usage rate of systemic antifungal agents

    During 4 weeks after the administration

  • Time to treatment failure

    During the study period

  • Assessment of Adverse events, Laboratory examinations and vital signs evaluation

    Throughout the study period

Study Arms (2)

1. Micafungin

EXPERIMENTAL
Drug: micafungin (Mycamine)

2. Itraconazole

ACTIVE COMPARATOR
Drug: itraconazole

Interventions

micafungin (Mycamine)DRUG

Intravenous

Also known as: Mycamine, FK463
1. Micafungin
itraconazoleDRUG

oral

Also known as: Sporanox
2. Itraconazole

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
  • Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant
  • Any patient undergoing an allogeneic hematopoietic stem cell transplant

You may not qualify if:

  • Patients with moderate or severe liver disease, as defined by:
  • AST or ALT greater than 5 times upper limit of normal (ULN), OR;
  • Total bilirubin greater than 2.5 times ULN
  • Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Fuzhou, Fujian, China

Location

Unknown Facility

Wuhan, Hubei, China

Location

Unknown Facility

Chengdu, Sichuan, China

Location

Unknown Facility

Hangzhou, Zhejiang, China

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Jiangsu, China

Location

Unknown Facility

Nanning, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Xi'an, China

Location

Related Publications (1)

  • Huang X, Chen H, Han M, Zou P, Wu D, Lai Y, Huang H, Chen X, Liu T, Zhu H, Wang J, Hu J. Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2012 Oct;18(10):1509-16. doi: 10.1016/j.bbmt.2012.03.014. Epub 2012 Mar 30.

    PMID: 22469884DERIVED

Related Links

MeSH Terms

Conditions

FungemiaMycoses

Interventions

MicafunginItraconazole

Condition Hierarchy (Ancestors)

Invasive Fungal InfectionsBacterial Infections and MycosesInfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsEchinocandinsPeptides, CyclicTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 20, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 28, 2016

Record last verified: 2016-03

Locations

CN(10)