Liver Transplant European Study Into the Prevention of Fungal Infection (TENPIN)
This study has been completed.
Sponsor:
Astellas Pharma Inc
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
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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:
Drug Information available for:
Amphotericin B
Fluconazole
Caspofungin
Caspofungin acetate
Micafungin sodium
Micafungin
Liposomal Amphotericin B
U.S. FDA Resources
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
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:
|
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 March 03, 2015