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.

Phase 1

• Conditions: Invasive fungal disease caused by Aspergillus species in patients with renal impairment as well as disease caused by rare moulds, yeasts or dimorphic fungi.; MedDRA version: 15.0 Level: HLT Classification code 10003486 Term: Aspergillus infections System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2006-005003-33-GB
• Lead Sponsor: Astellas Global Pharma Development, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-11-26
• Study Completion: 2014-01-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 149

Inclusion Criteria

1. Patients with proven/probable invasive fungal disease caused by Aspergillus who also have renal impairment (including dialysis)

2. Patients with proven/probable invasive fungal disease caused by rare moulds, yeasts and dimorphic fungi, whether really impaired or not (including dialysis)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A known condition of the patient that may jeopardize adherence to the protocol requirements
2. Patients who are unlikely to survive 30 days
3. Patients with a body weight < 40 kg
4. Women who are pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified