Randomized, Open label, Non-inferiority Study of Micafungin versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients - TENPIN (Liver Transplant EuropeaN study into the Prevention of fungal InfectioN)

• Register: EUCTR
• Last refreshed on: 5 November 2012
• Main ID: EUCTR2008-005214-49-PT
• Date of registration: 03/09/2009
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe Ltd
• Public 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 - TENPIN (Liver Transplant EuropeaN study into the Prevention of fungal InfectioN)
• 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 - TENPIN (Liver Transplant EuropeaN study into the Prevention of fungal InfectioN)
• Date of first enrolment: 06/11/2009
• Target sample size: 338
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-005214-49
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Belgium, Czech Republic, France, Germany, Hungary, Ireland, Italy, Portugal, Spain, Sweden, United Kingdom

Contacts

• Name: Natalie
• Affiliation: Astellas Pharma Europe Ltd

• Name: Natalie
• Affiliation: Astellas Pharma Europe Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age >= 18 years.
2. Undergoing orthotopic whole or split liver allograft transplantation.
3. 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-operative renal impairment (defined as creatinine clearance =40 ml/min) or need for renal replacement therapy
• Post-operative renal impairment (defined as creatinine clearance =40 ml/min) or need for renal replacement therapy within 5 days following liver transplant
• 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


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Any systemic antifungal therapy (excluding fluconazole or selective digestive decontamination for a maximum of 7 days) within 14 days prior to randomization.
2. Evidence of documented (‘proven’ or ‘probable’) or suspected (‘possible’) IFD (according to the EORTC/MSG criteria).
3. Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Fungal infection.
MedDRA version: 14.1 Level: LLT Classification code 10042941 Term: Systemic fungal infection NOS System Organ Class: 100000004862

Intervention(s)

Trade Name: Mycamine
Product Name: Micafungin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: MICAFUNGIN
CAS Number: 235114-32-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Cancidas
Product Name: Caspofungin
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: CASPOFUNGIN ACETATE
CAS Number: 179463-17-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: CASPOFUNGIN ACETATE
CAS Number: 179463-17-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 70-

Trade Name: Diflucan
Product Name: Fluconazole
Pharmaceutical Form:
INN or Proposed INN: FLUCONAZOLE
CAS Number: 86386-73-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-

Trade Name: AmBisome
Product Name: AmBisome
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Liposomal amphotericin B
CAS Number: 1397-89-3
Other descriptive name: AMPHOTERICINE B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): Clinical success

Secondary Objective: To assess;
• efficacy
• safety and tolerability
• fungal-free survival
• health economic variables
of micafungin versus ‘standard care’ in ‘high risk’ subjects undergoing liver transplantation.

Main Objective: To demonstrate non-inferiority of micafungin at a dose of 100 mg/day versus ‘standard care’ for the prevention of Invasive Fungal Disease, defined according to the revised EORTC/MSG criteria, in ‘high risk’ patients undergoing liver transplantation.

Secondary ID(s)

9463-EC-0001

2008-005214-49-BE

Source(s) of Monetary Support

Astellas Pharma Europe Ltd