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Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis

NCT00412893 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 527

Last updated 2024-12-10

Study results available
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Summary

The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.

Conditions

  • Aspergillosis
  • Invasive Fungal Infection

Interventions

DRUG

Isavuconazole

Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

DRUG

Voriconazole

Loading doses were administered as IV infusion and maintenance doses were administered as IV infusion or oral (capsules).

Sponsors & Collaborators

  • Basilea Pharmaceutica International Ltd

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-07
Primary Completion
2013-03-28
Completion
2013-03-28

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Egypt
  • France
  • Germany
  • Hungary
  • India
  • Israel
  • Italy
  • Malaysia
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Thailand
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00412893 on ClinicalTrials.gov