A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fungemia; Fungal Infections
Intervention: micafungin (Mycamine) (Drug); itraconazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Treatment success rate (fungal breakthrough rate)
Secondary outcome: Incidence of proven or probable invasive fungal infectionThe usage rate of systemic antifungal agents Time to treatment failure Assessment of Adverse events, Laboratory examinations and vital signs evaluation
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
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jiangsu, China
Nanning, China
Peking, China
Shanghai, China
Tianjin, China
Xian, China
Fuzhou, Fujian, China
Wuhan, Hubei, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Additional Information
Starting date: November 2008
Last updated: February 8, 2010
|
