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Liver Transplant European Study Into the Prevention of Fungal Infection (TENPIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01058174
First received: January 26, 2010
Last updated: November 26, 2013
Last verified: October 2012
  Purpose

Prevention of invasive fungal infection in high risk patients following liver transplant.


Condition Intervention Phase
Liver Transplantation
Mycoses
Drug: micafungin
Drug: fluconazole
Drug: liposomal amphotericin B
Drug: caspofungin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator [ Time Frame: up to 21 days & 3 months ] [ Designated as safety issue: No ]
  • Time to 'proven' or 'probable' IFD [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Fungal free survival at the End of Study and at the end of Long-term Follow-up [ Time Frame: 3 months & 6 months ] [ Designated as safety issue: No ]
  • Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Enrollment: 350
Study Start Date: December 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: micafungin Drug: micafungin
intravenous infusion
Other Name: Mycamine
Active Comparator: standard care Drug: fluconazole
intravenous infusion
Other Name: Diflucan
Drug: liposomal amphotericin B
intravenous infusion
Other Name: AmBisome
Drug: caspofungin
intravenous infusion
Other Name: Cancidas

Detailed Description:

After receiving liver transplant, subjects will be randomized to one of the two treatment arms.

Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first.

Additionally, mortality data will be collected at the Long-term Follow-up.

  Eligibility

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

Inclusion Criteria:

  • Undergoing orthotopic whole or split liver allograft transplantation
  • Patients at 'high risk' of invasive fungal infection due to the presence of at least one of the following risk factors:

    • Re-transplantation
    • Acute liver failure
    • Pre- or post-operative renal impairment (defined as creatinine clearance ≤40 ml/min) or need for renal replacement therapy
    • Admission to Intensive Care Unit (ICU) for greater than 48 hours prior to liver transplant
    • Re-operation (abdominal surgery) within 5 days of liver transplant
    • Presence of choledocojejunostomy
    • Perioperative colonization with fungi, defined as two or more positive clinical site surveillance cultures for Candida spp., obtained within 96 hours before or after liver transplant
    • Need for prolonged mechanical ventilation for greater than 48 hours following liver transplant
    • Transfusion intraoperatively of 20 or more units of cellular blood products
  • Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain effective birth control during the study

Exclusion Criteria:

  • Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum of 7 days) within 14 days prior to randomization
  • Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria)
  • Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058174

  Show 36 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01058174     History of Changes
Other Study ID Numbers: 9463-EC-0001, 2008-005214-49
Study First Received: January 26, 2010
Last Updated: November 26, 2013
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ethics Committee
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation
Saudi Arabia: Ministry of Health
Romania: National Medicines Agency
Sweden: Medical Products Agency

Keywords provided by Astellas Pharma Inc:
Liver transplantation
Prophylaxis
Prevention
Mycoses
Invasive Fungal Infection
Micafungin

Additional relevant MeSH terms:
Mycoses
Amphotericin B
Liposomal amphotericin B
Micafungin
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014