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Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study
Conditions
Liver Failure - Liver Diseases - Liver Cirrhosis - Liver Neoplasms
Conditions: official terms
Liver Cirrhosis - Liver Diseases - Liver Failure - Liver Neoplasms
Conditions: Keywords
Liver Transplantation, Graft Rejection, Graft Survival, Transplantation Immunology, Anti-Rejection Therapy, Immunosuppression, Organ Transplantation, Host vs Graft Reaction, Gastroenterology, Hepatology
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Everolimus
Type: Drug
Overall Status
Recruiting
Summary
Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.
Detailed Description
This prospective study was designed to evaluate the feasibility and effectiveness of the use of Everolimus in the minimization and possible suspension of calcineurin inhibitors in adult liver transplant patients. The study will take into account a control group (standard immunosuppression with tacrolimus and steroids) after induction with anti-IL2 Antibodies.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Male or female patients between 18 and 70 years of age,
- Patients undergoing de novo liver transplantation from cadaveric donor with a functional graft at the time of randomization,
- Transplantation from cadaveric donor whole or split liver,
- Patients able to communicate properly with the study investigators, to understand and respond to the needs of the protocol and who have given written consent
- Cold ischemia time <12 hours
Exclusion Criteria:
- Physical or laboratory abnormalities or mental illness within 2 weeks before randomization such that, in the opinion of the investigator, may interfere with participation in the study
- Women who are pregnant (positive test with hCG values> 5mUI/ml) or breast-feeding
- Women of childbearing potential, with the following exceptions: a) women in menopause (spontaneous amenorrhea for at least 12 months, spontaneous amenorrhea for at least 6 months with FSH levels >40 mIU/ml, surgical bilateral oophorectomy at least 6 weeks before baseline, with or without hysterectomy) b) women who use one or more reliable and approved methods of contraception for the duration of the study and for the three months following discontinuation of study treatment.
- Patients who undergo transplantation or multivisceral transplantation of pancreatic islets, or who have previously undergone organ transplantation or tissue.
- Patients who undergo combined liver-kidney transplantation
- Patients who undergo living donor liver transplantation
- Patients who undergo ABO-incompatible liver transplantation
- Patients who undergo transplantation from donors positive for HBV surface antigen or HIV
- History of malignant disease at any site in the 3 year period prior, regardless of whether or not there is evidence of recurrence or metastasis. (Except non-metastatic skin cancers such as basal cell or squamous cell carcinoma of the skin, or hepatocellular carcinoma)
- Patients receiving other investigational drugs within 4 weeks before baseline or who are currently enrolled in other clinical trials
- Patients who show hypersensitivity to the drug (or drugs similar to Everolimus - Former macrolides) or class or pharmaceutical excipients. Also, when there are contraindications
- A history of coagulopathy or the presence of any medical condition that requires long-term anticoagulant therapy after transplantation (The use of low-dose ASA is admissible)
- Platelet count <=40.000/mm3 or WBC count <2000/mm3 or hemoglobin <=7g/dl at the time of randomization
- Severe systemic infections
- High cholesterol levels (>350mg/dl) or severe hypertriglyceridemia (>500mg/dl). Patients with compensated hyperlipidemia are eligible.
- Diagnosis of pre-transplant autoimmune liver disease (PBC, sclerosing cholangitis)
- Acute Liver Failure
- Male or female patients between 18 and 70 years of age,
- Patients undergoing de novo liver transplantation from cadaveric donor with a functional graft at the time of randomization,
- Transplantation from cadaveric donor whole or split liver,
- Patients able to communicate properly with the study investigators, to understand and respond to the needs of the protocol and who have given written consent
- Cold ischemia time <12 hours
Exclusion Criteria:
- Physical or laboratory abnormalities or mental illness within 2 weeks before randomization such that, in the opinion of the investigator, may interfere with participation in the study
- Women who are pregnant (positive test with hCG values> 5mUI/ml) or breast-feeding
- Women of childbearing potential, with the following exceptions: a) women in menopause (spontaneous amenorrhea for at least 12 months, spontaneous amenorrhea for at least 6 months with FSH levels >40 mIU/ml, surgical bilateral oophorectomy at least 6 weeks before baseline, with or without hysterectomy) b) women who use one or more reliable and approved methods of contraception for the duration of the study and for the three months following discontinuation of study treatment.
- Patients who undergo transplantation or multivisceral transplantation of pancreatic islets, or who have previously undergone organ transplantation or tissue.
- Patients who undergo combined liver-kidney transplantation
- Patients who undergo living donor liver transplantation
- Patients who undergo ABO-incompatible liver transplantation
- Patients who undergo transplantation from donors positive for HBV surface antigen or HIV
- History of malignant disease at any site in the 3 year period prior, regardless of whether or not there is evidence of recurrence or metastasis. (Except non-metastatic skin cancers such as basal cell or squamous cell carcinoma of the skin, or hepatocellular carcinoma)
- Patients receiving other investigational drugs within 4 weeks before baseline or who are currently enrolled in other clinical trials
- Patients who show hypersensitivity to the drug (or drugs similar to Everolimus - Former macrolides) or class or pharmaceutical excipients. Also, when there are contraindications
- A history of coagulopathy or the presence of any medical condition that requires long-term anticoagulant therapy after transplantation (The use of low-dose ASA is admissible)
- Platelet count <=40.000/mm3 or WBC count <2000/mm3 or hemoglobin <=7g/dl at the time of randomization
- Severe systemic infections
- High cholesterol levels (>350mg/dl) or severe hypertriglyceridemia (>500mg/dl). Patients with compensated hyperlipidemia are eligible.
- Diagnosis of pre-transplant autoimmune liver disease (PBC, sclerosing cholangitis)
- Acute Liver Failure
Locations
Ospedali Riuniti - Bergamo
Bergamo, BG, Italy
Irccs Ospedale Maggiore Policlinico Di Milano
Status: Recruiting
Contact: Michele Colledan, MD - +39 035 269111 - mcolledan@ospedaliriuniti.bergamo.it
Milano, MI, Italy
Ospedale Ca` Granda-Niguarda - Milano
Status: Recruiting
Contact: Giorgio Rossi, MD - +39 02 55031 - giorgio.rossi@unimi.it
Milano, MI, Italy
Azienda Ospedaliera di Padova
Status: Recruiting
Contact: Luciano De Carlis, MD - +39 02 64441 - Luciano.DeCarlis@ospedaleniguarda.it
Padua, PD, Italy
Policlinico Universitario Gemelli Di Roma
Status: Recruiting
Contact: Umberto Cillo, MD - +390498218624 - cillo@unipd.it
Roma, RM, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino
Status: Recruiting
Contact: Salvatore Agnes, MD - +39 06 3550 1928 - salvatoreagnes@rm.unicatt.it
Torino, TO, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Status: Recruiting
Contact: Mauro Salizzoni, MD - +39 011 633 1633 - msalizzoni@molinette.piemonte.it
Udine, UD, Italy
Status: Recruiting
Contact: Fabio Bresàdola, MD - +39 0432 5521 - fabrizio.bresadola@dsc.uniud.it
Start Date
February 2010
Completion Date
January 2014
Sponsors
Azienda Ospedaliera di Padova
Source
Azienda Ospedaliera di Padova
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page