Adult recipients of first liver transplantation MedDRA version: 9.1 Level: LLT Classification code 10024715 Term: Liver transplant rejection
Conditions
Interventions
Trade Name: THYMOGLOBULINE*1F 25MG 10ML
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Antithymocyte immunoglobulin (rabbit)
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with first liver transplant procedure, even split or living-related, of age > 18 years, giving informed consent to inclusion in the study protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1)Re-transplantation with any indication 2)HIV+ patients, or with tumours different from HCC 3)Recipients of multiorgan procedures 4)Patients with severe lymphopenia (< 1000 WBC/ul) or thrombocitopenia (< 50000 PLT/ul) pre-transplantation 5)Female patients in fertile age during pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Induction of donor-specific tolerance in patients with liver transplantation by means of a recipient pretreatment with Thymoglobuline;Secondary Objective: 1) Evaluation of clinical efficacy of two different minimation regimes of immunosuppression with respect to success and duration of the weaning; 2) Evaluation of efficacy and safety with respect to adverse events impacting long-term patient and graft survival: acute and chronic rejection; HCV recurrence, HCC recurrence; death for septicaemia; permanent nefro- and neuro-toxicity; development of metabolic disturbances requiring therapy. 3)Prospective evaluation of biologic machanisms related to induction of tolerance, by means of serial blood and tissue sampling of Treg lymphocytes CD4CD25FOXP3.;Primary end point(s): 1)absolute number (cells/mcL) and percentage of T-regulators lymphocytes CD4CD25FOXP3 in each group of patients after 12 months from transplantation. 2)rejection-free survival at 6, 12 and 24 months post-transplantation in each group; 3)Patients and graft survival at 6, 12 and 24 months post-transplantation in the two study groups; 4)Incidence of acute and chronic rejection histologically proven, requiring therapy, incidence of success of therapy and time to onset of event 5)Incidence of patients A) starting the ?weaning? process B) time of permanence in ?weaning? and C) correlation to rejection episodes 5)Incidence and type of adverse events related to immunosuppression, particularly lymphopenia, neutropenia e thrombocitopenia, numbers and percentage of patients requiring treatment and interruption of drug administration; 6)Incidence of immunosuppression-related adverse events with respect to: A) viral infections (CMV, EBV, HHV6, HHV8), or sistemic fengemia or bacterial septicaemia requiring treatment; B) onset of blood hypertension, diabetes mellitus, nefro- or neurotoxicity requiring treatment and/or switching between immunosuppressive drugs and relation with blood level | — |
Countries
Italy
Outcome results
None listed