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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: June 5, 2015
Last verified: June 2015
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]
  • 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 ]
  • Time to 'proven' or 'probable' IFD [ Time Frame: up to 3 months ]
  • Fungal free survival at the End of Study and at the end of Long-term Follow-up [ Time Frame: 3 months & 6 months ]
  • Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [ Time Frame: up to 21 days ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01058174     History of Changes
Other Study ID Numbers: 9463-EC-0001
2008-005214-49 ( EudraCT Number )
Study First Received: January 26, 2010
Last Updated: June 5, 2015

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

Additional relevant MeSH terms:
Mycoses
Fluconazole
Amphotericin B
Liposomal amphotericin B
Micafungin
Echinocandins
Caspofungin
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on September 25, 2017