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

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

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

Study Overview

• Status: Completed
• Conditions: Fungemia; Fungal Infections
• Intervention / Treatment: Drug: itraconazole; Drug: micafungin (Mycamine)

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 Type: Interventional
• Enrollment (Actual): 288
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu, China
  • Nanning, China
  • Peking, China
  • Shanghai, China
  • Tianjin, China
  • Xian, China
  • Fujian
    • Fuzhou, Fujian, China
  • Hubei
    • Wuhan, Hubei, China
  • Sichuan
    • Chengdu, Sichuan, China
  • Zhejiang
    • Hangzhou, Zhejiang, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment success rate (fungal breakthrough rate)	At the end of the study

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: November 19, 2008
• First Submitted That Met QC Criteria: November 19, 2008
• First Posted (Estimate): November 20, 2008

Study Record Updates

• Last Update Posted (Estimate): March 28, 2016
• Last Update Submitted That Met QC Criteria: March 25, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: micafungin; itraconazole; Antifungal
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Bacterial Infections and Mycoses; Sepsis; Invasive Fungal Infections; Infections; Communicable Diseases; Mycoses; Fungemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Micafungin; Itraconazole
• Other Study ID Numbers: MCFGCN02-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED