A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00794703

Collaborator

(none)

288

Enrollment

Locations

Arms

Duration (Months)

28.8

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fungemia Fungal Infections	Drug: micafungin (Mycamine) Drug: itraconazole	Phase 3

Detailed Description

Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days

Study Design

Study Type:

Interventional

Actual Enrollment :

288 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Micafungin	Drug: micafungin (Mycamine) Intravenous Other Names: Mycamine FK463
Active Comparator: 2. Itraconazole	Drug: itraconazole oral Other Names: Sporanox

Arm

Intervention/Treatment

Experimental: 1. Micafungin

Drug: micafungin (Mycamine)

Intravenous

Other Names:

Mycamine

FK463

Active Comparator: 2. Itraconazole

Drug: itraconazole

oral

Other Names:

Sporanox

Outcome Measures

Primary Outcome Measures

Treatment success rate (fungal breakthrough rate) [At the end of the study]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	City	State	Country
1	Fuzhou	Fujian	China
2	Wuhan	Hubei	China
3	Chengdu	Sichuan	China
4	Hangzhou	Zhejiang	China
5	Jiangsu		China
6	Nanning		China
7	Peking		China
8	Shanghai		China
9	Tianjin		China
10	Xian		China