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

Fungal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794703
• Other study ID #: MCFGCN02-0
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2008
• Last updated: March 25, 2016
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: March 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fungal Infections
• Fungemia
• Infection
• Mycoses

Intervention

Drug:
• micafungin (Mycamine)
Intravenous
• itraconazole
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment success rate (fungal breakthrough rate)		At the end of the study	No
Secondary	Incidence of proven or probable invasive fungal infection		Throughout the study period	No
Secondary	The usage rate of systemic antifungal agents		During 4 weeks after the administration	No
Secondary	Time to treatment failure		During the study period	No
Secondary	Assessment of Adverse events, Laboratory examinations and vital signs evaluation		Throughout the study period	No

External Links

•   Link to results on Astellas Clinical Study Results Web site