Liver Transplant European Study Into the Prevention of Fungal Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01058174
• Date of registration: 26/01/2010
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Inc
• Public title: Liver Transplant European Study Into the Prevention of Fungal Infection TENPIN
• Scientific 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
• Date of first enrolment: December 15, 2009
• Target sample size: 350
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01058174
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Hungary, Ireland, Italy, Portugal, Romania, Russian Federation, Saudi Arabia, Spain, Sweden, United Kingdom

Contacts

• Name: Use Central Contact
• Affiliation: Astellas Pharma Europe Ltd.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Liver Transplantation

Mycoses

Intervention(s)

Drug: micafungin

Drug: fluconazole

Drug: caspofungin

Drug: liposomal amphotericin B

Primary Outcome(s)

'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). [Time Frame: up to 21 days]

Secondary Outcome(s)

Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [Time Frame: up to 21 days]

Fungal free survival at the End of Study and at the end of Long-term Follow-up [Time Frame: 3 months & 6 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]

Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [Time Frame: 3 months]

Time to 'proven' or 'probable' IFD [Time Frame: up to 3 months]

Secondary ID(s)

2008-005214-49

9463-EC-0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors