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Trial Title: Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

NCT ID: NCT01423708

Condition: Liver Failure
Liver Diseases
Liver Cirrhosis
Liver Neoplasms

Conditions: Official terms:
Liver Neoplasms
Liver Diseases
Liver Cirrhosis
Liver Failure
Everolimus

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

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Everolimus
Description: Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of >5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels <5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.
Arm group label: Everolimus

Other name: Certican

Other name: Afinitor

Other name: Zortress

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:
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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ospedali Riuniti - Bergamo

Address:
City: Bergamo
Zip: 24128
Country: Italy

Status: Recruiting

Contact:
Last name: Michele Colledan, MD

Phone: +39 035 269111
Email: mcolledan@ospedaliriuniti.bergamo.it

Contact backup:
Last name: Vittorio Corno, MD

Phone: +39 035 269111
Email: vcorno@ospedaliriuniti.bergamo.it

Investigator:
Last name: Michele Colledan, MD
Email: Principal Investigator

Investigator:
Last name: Vittorio Corno, MD
Email: Sub-Investigator

Facility:
Name: Irccs Ospedale Maggiore Policlinico Di Milano

Address:
City: Milano
Zip: 20122
Country: Italy

Status: Recruiting

Contact:
Last name: Giorgio Rossi, MD

Phone: +39 02 55031
Email: giorgio.rossi@unimi.it

Contact backup:
Last name: Paolo Reggiani, MD

Phone: +39 02 55031
Email: paolo.reggiani@policlinico.mi.it

Investigator:
Last name: Giorgio Rossi, MD
Email: Principal Investigator

Investigator:
Last name: Paolo Reggiani, MD
Email: Sub-Investigator

Facility:
Name: Ospedale Ca' Granda-Niguarda - Milano

Address:
City: Milano
Zip: 20162
Country: Italy

Status: Recruiting

Contact:
Last name: Luciano De Carlis, MD

Phone: +39 02 64441
Email: Luciano.DeCarlis@ospedaleniguarda.it

Contact backup:
Last name: Jacopo Mangoni, MD

Phone: +39 02 64441
Email: jacopo.mangoni@libero.it

Investigator:
Last name: Luciano De Carlis, MD
Email: Principal Investigator

Investigator:
Last name: Jacopo Mangoni, MD
Email: Sub-Investigator

Facility:
Name: Azienda Ospedaliera di Padova

Address:
City: Padua
Zip: 35128
Country: Italy

Status: Recruiting

Contact:
Last name: Umberto Cillo, MD

Phone: +390498218624
Email: cillo@unipd.it

Contact backup:
Last name: Laura Saracino, MBS

Phone: +390498218624
Email: lasaracino@gmail.com

Investigator:
Last name: Umberto Cillo, MD
Email: Principal Investigator

Investigator:
Last name: Giacomo Zanus, MD
Email: Sub-Investigator

Investigator:
Last name: Daniele Neri, MD
Email: Sub-Investigator

Investigator:
Last name: Patrizia Boccagni, MD
Email: Sub-Investigator

Investigator:
Last name: Francesco D'Amico, MD
Email: Sub-Investigator

Investigator:
Last name: Enrico Gringeri, MD
Email: Sub-Investigator

Investigator:
Last name: Alessandro Vitale, MD
Email: Sub-Investigator

Investigator:
Last name: Pasquale Bonsignore, MD
Email: Sub-Investigator

Investigator:
Last name: Paolo Feltracco, MD
Email: Sub-Investigator

Investigator:
Last name: Dino Sgarabotto, MD
Email: Sub-Investigator

Investigator:
Last name: Roberto Marchini, MD
Email: Sub-Investigator

Investigator:
Last name: Angelica Magrofuoco, CCTC
Email: Sub-Investigator

Investigator:
Last name: Laura Saracino, MSc
Email: Sub-Investigator

Facility:
Name: Policlinico Universitario Gemelli Di Roma

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Salvatore Agnes, MD

Phone: +39 06 3550 1928
Email: salvatoreagnes@rm.unicatt.it

Contact backup:
Last name: Erida Nure, MD

Phone: +39 06 3550 1928
Email: eridanure@yahoo.it

Investigator:
Last name: Erida Nure, MD
Email: Sub-Investigator

Investigator:
Last name: Salvatore Agnes, MD
Email: Principal Investigator

Facility:
Name: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino

Address:
City: Torino
Zip: 10126
Country: Italy

Status: Recruiting

Contact:
Last name: Mauro Salizzoni, MD

Phone: +39 011 633 1633
Email: msalizzoni@molinette.piemonte.it

Contact backup:
Last name: Francesco Lupo, MD

Phone: +39 011 633 1633
Email: flupo@molinette.piemonte.it

Investigator:
Last name: Mauro Salizzoni, MD
Email: Principal Investigator

Investigator:
Last name: Francesco Lupo, MD
Email: Sub-Investigator

Facility:
Name: A.O. Universitaria S. Maria Della Misericordia Di Udine

Address:
City: Udine
Zip: 33100
Country: Italy

Status: Recruiting

Contact:
Last name: Fabio Bresàdola, MD

Phone: +39 0432 5521
Email: fabrizio.bresadola@dsc.uniud.it

Contact backup:
Last name: Umberto Baccarani, MD

Phone: +39 0432 5521
Email: umberto.baccarani@dsc.uniud.it

Investigator:
Last name: Umberto Baccarani, MD
Email: Sub-Investigator

Investigator:
Last name: Fabio Bresàdola, MD
Email: Principal Investigator

Start date: February 2010

Completion date: January 2014

Lead sponsor:
Agency: Azienda Ospedaliera di Padova
Agency class: Other

Source: Azienda Ospedaliera di Padova

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01423708
http://www.fegatochirurgia.com/

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