Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi

Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
This study is currently recruiting participants.
Verified May 2012 by Astellas Pharma Inc

First Received on March 5, 2008.  
Last Updated on May 2, 2012  
History of Changes
Sponsor: Astellas Pharma Inc
Collaborator: Basilea Pharmaceutica
Information provided by (Responsible Party): Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00634049
  Purpose

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.

Condition Intervention Phase
Aspergillosis
Invasive Fungal Infections
Drug: isavuconazole Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

  • 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

Secondary Outcome Measures:

  • 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 ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: Isavuconazole 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with proven/probable invasive fungal disease caused by Aspergillus and who have also renal impairment
  • patients with proven/probable invasive fungal disease caused by rare moulds, yeasts and dimorphic fungi

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00634049

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

 
Show 159 Study Locations

Sponsors and Collaborators
Astellas Pharma Inc
Basilea Pharmaceutica
Investigators
Study Director: Medical Director Astellas Pharma Global Development
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00634049    
History of Changes
Other Study ID Numbers: 9766-CL-0103, WSA-CS-003, 2006-005003-33
Study First Received: March 5, 2008
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Egypt: Ministry of Health and Population
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials – Ministry of Health
Lebanon: Ministry of Public Health
Mexico: Secretaria de Salud
Malaysia: Ministry of Health
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health and Social Development of the Russian Federation
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Food and Drug Administration
France: Afssaps – Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:

Aspergillosis in patients with renal disease
invasive fungal infections caused by rare molds, rare yeasts
or by dimorphic fungi
Isavuconazole
ASP9766
BAL8557

Additional relevant MeSH terms:

Aspergillosis
Mycoses

ClinicalTrials.gov processed this record on August 21, 2012

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