Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Basilea Pharmaceutica International Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00634049
First received: March 5, 2008
Last updated: March 21, 2014
Last verified: March 2014

March 5, 2008
March 21, 2014
April 2008
January 2014   (final data collection date for primary outcome measure)
Overall outcome of treatment evaluated by Data Review Committee (DRC) [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
Based on the assessments of clinical, mycological and radiological response
Overall outcome of treatment (clinical, mycological and radiological response) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00634049 on ClinicalTrials.gov Archive Site
  • Overall outcome of treatment evaluated by Investigator [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Based on the assessments of clinical, mycological and radiological response
  • Overall outcome at end of treatment and Day 84 assessed by DRC and Investigator [ Time Frame: Day 84 and end of treatment (up to Day 180) ] [ Designated as safety issue: No ]
    Based on the assessments of clinical, mycological and radiological response
  • Clinical response assessed by DRC and Investigator [ Time Frame: Day 42, Day 84, end of treatment (up to Day 180) and 4 weeks after last study dose ] [ Designated as safety issue: No ]
  • Mycological response by DRC and Investigator [ Time Frame: Day 42, Day 84, end of treatment (up to Day 180) and 4 weeks after last study dose ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: Day 42, Day 84, Day 120 and Day 180 ] [ Designated as safety issue: No ]
  • Clinical response by sub-group [ Designated as safety issue: No ]
  • Mycological response by pathogen group [ Designated as safety issue: No ]
  • Survival status by subgroup [ Designated as safety issue: No ]
  • Overall incidence of adverse events, clinically significant laboratory changes, physical examination, vital signs, ECG, concomitant medication [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
Open Label Study of Isavuconazole in the Treatment of Patients With Aspergillosis and Renal Impairment or of Patients With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

The purpose of this study is to investigate the safety and efficacy of isavuconazole in the treatment of invasive fungal infections that are caused by Aspergillus (in renally impaired patients)and rare fungi.

Acute invasive fungal infections caused by aspergillus, rare moulds, yeasts or dimorphic fungi are life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. Isavuconazole is not approved for the treatment of fungal infections. This study investigates the safety and efficacy of isavuconazole in patients with aspergillosis and renal impairment, and in patients suffering from invasive infections from rare fungi.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aspergillosis
  • Invasive Fungal Infections
Drug: isavuconazole
Administration of 200mg isavuconazole tree times a day iv or oral (in the vein or as a capsule for 2 days, followed by daily administration of 200mg isavuconazole iv or oral
Other Names:
  • ASP9766
  • BAL8557
Experimental: Isavuconazole
Intervention: Drug: isavuconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
April 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients meeting EORTC/MSG (European Organization for the Research and Treatment of Cancer/Mycoses Study Group) definition of proven or culture positive probable IFD (invasive fungal disease) caused by rare molds, yeasts, or dimorphic fungi (i.e. fungal pathogens other than Aspergillus or Candida species) whether renally impaired or not (including dialysis) who require primary therapy for their IFD at the time of enrollment.

OR

  • Patients who have proven or probable zygomycosis, whether renally impaired or not (including dialysis), who require primary therapy. Zygomycosis must be documented by culture or histology / cytology.

Exclusion Criteria:

  • a known condition of the patient that may jeopardize adherence to the protocol requirements
  • Patients who are unlikely to survive 30 days
  • Patients with a body weight < 40 kg
  • Women who are pregnant or breastfeeding
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Egypt,   France,   Germany,   India,   Israel,   Korea, Republic of,   Lebanon,   Mexico,   Poland,   Russian Federation,   South Africa,   Thailand,   United Kingdom
 
NCT00634049
9766-CL-0103, WSA-CS-003, 2006-005003-33
Yes
Astellas Pharma Inc
Astellas Pharma Inc
Basilea Pharmaceutica International Ltd
Study Director: Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP