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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 evaluation

Requests 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

Page last updated: August 23, 2015

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