Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study
Information source: Azienda Ospedaliera di Padova
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Failure; Liver Diseases; Liver Cirrhosis; Liver Neoplasms
Intervention: Everolimus (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Azienda Ospedaliera di Padova Official(s) and/or principal investigator(s): Umberto Cillo, MD, Study Chair, Affiliation: Azienda Ospedaliera di Padova
Overall contact: Umberto Cillo, MD, Phone: +390498218624, Email: cillo@unipd.it
Summary
Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.
Clinical Details
Official title: Terapia Con Everolimus Nel Trapianto de Novo di Fegato: Uno Studio Multicentrico Randomizzato
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Biopsy-proven rejection episodes (BPAR)Graft survival Patient post-Liver Transplantation survival Everolimus monotherapy
Secondary outcome: Renal function evaluationRequests for dialysis Incidence of Adverse Events
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): 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
Locations and Contacts
Umberto Cillo, MD, Phone: +390498218624, Email: cillo@unipd.it
Ospedali Riuniti - Bergamo, Bergamo, BG 24128, Italy; Recruiting Michele Colledan, MD, Phone: +39 035 269111, Email: mcolledan@ospedaliriuniti.bergamo.it Vittorio Corno, MD, Phone: +39 035 269111, Email: vcorno@ospedaliriuniti.bergamo.it Michele Colledan, MD, Principal Investigator Vittorio Corno, MD, Sub-Investigator
Irccs Ospedale Maggiore Policlinico Di Milano, Milano, MI 20122, Italy; Recruiting Giorgio Rossi, MD, Phone: +39 02 55031, Email: giorgio.rossi@unimi.it Paolo Reggiani, MD, Phone: +39 02 55031, Email: paolo.reggiani@policlinico.mi.it Giorgio Rossi, MD, Principal Investigator Paolo Reggiani, MD, Sub-Investigator
Ospedale Ca` Granda-Niguarda - Milano, Milano, MI 20162, Italy; Recruiting Luciano De Carlis, MD, Phone: +39 02 64441, Email: Luciano.DeCarlis@ospedaleniguarda.it Jacopo Mangoni, MD, Phone: +39 02 64441, Email: jacopo.mangoni@libero.it Luciano De Carlis, MD, Principal Investigator Jacopo Mangoni, MD, Sub-Investigator
Azienda Ospedaliera di Padova, Padua, PD 35128, Italy; Recruiting Umberto Cillo, MD, Phone: +390498218624, Email: cillo@unipd.it Laura Saracino, MBS, Phone: +390498218624, Email: lasaracino@gmail.com Umberto Cillo, MD, Principal Investigator Giacomo Zanus, MD, Sub-Investigator Daniele Neri, MD, Sub-Investigator Patrizia Boccagni, MD, Sub-Investigator Francesco D'Amico, MD, Sub-Investigator Enrico Gringeri, MD, Sub-Investigator Alessandro Vitale, MD, Sub-Investigator Pasquale Bonsignore, MD, Sub-Investigator Paolo Feltracco, MD, Sub-Investigator Dino Sgarabotto, MD, Sub-Investigator Roberto Marchini, MD, Sub-Investigator Angelica Magrofuoco, CCTC, Sub-Investigator Laura Saracino, MSc, Sub-Investigator
Policlinico Universitario Gemelli Di Roma, Roma, RM 00168, Italy; Recruiting Salvatore Agnes, MD, Phone: +39 06 3550 1928, Email: salvatoreagnes@rm.unicatt.it Erida Nure, MD, Phone: +39 06 3550 1928, Email: eridanure@yahoo.it Erida Nure, MD, Sub-Investigator Salvatore Agnes, MD, Principal Investigator
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino, Torino, TO 10126, Italy; Recruiting Mauro Salizzoni, MD, Phone: +39 011 633 1633, Email: msalizzoni@molinette.piemonte.it Francesco Lupo, MD, Phone: +39 011 633 1633, Email: flupo@molinette.piemonte.it Mauro Salizzoni, MD, Principal Investigator Francesco Lupo, MD, Sub-Investigator
A.O. Universitaria S. Maria Della Misericordia Di Udine, Udine, UD 33100, Italy; Recruiting Fabio Bresàdola, MD, Phone: +39 0432 5521, Email: fabrizio.bresadola@dsc.uniud.it Umberto Baccarani, MD, Phone: +39 0432 5521, Email: umberto.baccarani@dsc.uniud.it Umberto Baccarani, MD, Sub-Investigator Fabio Bresàdola, MD, Principal Investigator
Additional Information
Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy)
Starting date: February 2010
Last updated: July 17, 2012
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