Patients with liverfailure above 18 years of age, who is submitted to the waiting list for a liver transplantation
Conditions
Interventions
Trade Name: Mabthera
Product Name: Mabthera
Product Code: RO 45-2294/V02
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Current Sponsor
Sponsors
Sahlgrenska Universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are put on the livertransplant waiting list Age above 18 y First time liver transplantation recipients of liver graft from deceased donor Recipient who have given informed concent Patients who are presumed to be able to cooperate and follow 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: Severe ongoing infection Hepatitis B and C infection Known malignancy Age below 18 y Previously liver transplanted Recipients who are unable to give informed concent Recipients with bloodgroup AB Pregnant or breast feeding females Patients who on external circumstances and or psychiatric problems are thought to have difficulties to cooperate and or to follow the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine if a combination of Rituximab and immuneadsorbtion can elliminate ABO bloddgroup barrier in ABO incompatible livertransplantation to access if the procedure have equal results as compared to livertransplantation within bloodgroups.;Secondary Objective: To evaluate Rituximabs effects in patients with liver failure with regard to safety, Tx results and on the blood cellular level.;Primary end point(s): Composite endpoint: death, graft loss and biopsy verified acute rejection within 3 and 12 months after the transplantation. | — |
Countries
Sweden
Outcome results
None listed