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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005003-33-GB

Enrollment

100

Registered

2007-11-26

Start date

2008-06-26

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Product Name: Isavuconazonium sulphate Product Code: BAL8557 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Isavuconazonium sulfate

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Time Frame: Day 42 ;Main Objective: To describe the safety and efficacy of isavuconazole in the treatment of invasive aspergillosis in patients with renal impairment or in patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi.; Secondary Objective: The secondary objectives are to determine clinical and mycological response rate by pathogen. To evaluate the survival status at Day 42, 84, 120 and 180 ; Primary end point(s): Overall outcome of treatment evaluated by Data Review Committee (DRC). Based on the assessments of clinical, mycological and radiological response	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Time Frame: Day 42 ;Main Objective: To describe the safety and efficacy of isavuconazole in the treatment of invasive aspergillosis in patients with renal impairment or in patients with invasive fungal disease caused by rare moulds, yeasts or dimorphic fungi.; Secondary Objective: The secondary objectives are to determine clinical and mycological response rate by pathogen. To evaluate the survival status at Day 42, 84, 120 and 180 ; Primary end point(s): Overall outcome of treatment evaluated by Data Review Committee (DRC). Based on the assessments of clinical, mycological and radiological response

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Secondary

Measure	Time frame
Secondary end point(s): •Overall outcome of treatment evaluated by Investigator Based on the assessments of clinical, mycological and radiological response •Overall outcome at end of treatment and Day 84 assessed by DRC and Investigator by sub-group Based on the assessments of clinical, mycological and radiological response •Clinical response assessed by DRC and Investigator by sub-group •Mycological response by DRC and Investigator by sub-group •Survival rate ; Timepoint(s) of evaluation of this end point: •Overall outcome of treatment evaluated by Investigator [ Time Frame: Day 42 ] •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) ] •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 ] •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 ] •Survival rate [ Time Frame: Day 42, Day 84, Day 120 and Day 180 ]	—

Measure

Time frame

Secondary end point(s): •Overall outcome of treatment evaluated by Investigator Based on the assessments of clinical, mycological and radiological response •Overall outcome at end of treatment and Day 84 assessed by DRC and Investigator by sub-group Based on the assessments of clinical, mycological and radiological response •Clinical response assessed by DRC and Investigator by sub-group •Mycological response by DRC and Investigator by sub-group •Survival rate ; Timepoint(s) of evaluation of this end point: •Overall outcome of treatment evaluated by Investigator [ Time Frame: Day 42 ] •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) ] •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 ] •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 ] •Survival rate [ Time Frame: Day 42, Day 84, Day 120 and Day 180 ]

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Countries

Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Egypt, Germany, Hungary, India, Israel, Mexico, Russian Federation, South Africa, Spain, United Kingdom, United States

Contacts

Public Contactcontact@nl.astellas.com

Global Development Operations

contact@nl.astellas.com+31 71 54 55878

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026