REP0211A Phase 3, Multicenter, Randomized, Double-blind, Parallel Assignment Study to Assess the Efficacy and Safety of Reparixin in Pancreatic Islet Transplantation

Study start date: October 1, 2012

Inclusion Criteria: Ages 18-70 years, inclusive. Patients eligible for a pancreatic islet transplantation program Planned intrahepatic islet transplantation alone from a non-living donor with brain death. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations. Patients who have given written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Exclusion Criteria: Recipients of any previous transplant, including recipients of previous pancreatic islet transplantation. Recipients of islet from a non-heart beating donor. Pre-transplant average daily insulin requirement >1 IU/kg/day. Pre-transplant (the more recent value obtained within the 4 months prior to enrolment) HbA1c >11%. Patients with inadequate renal reserve as per calculated creatinine clearance (CLcr) < 60 mL/min according to the Cockcroft-Gault formula (1976). Patients with hepatic dysfunction as defined by increased ALT (alanine aminotranferase) / AST (aspartate aminotransferase) > 3 x upper limit of normal (ULN) and increased total bilirubin > 3mg/dL [>51.3 µmol/L]). Patients who receive treatment for a medical condition requiring chronic use of systemic steroids. Treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant. Use of any investigational agent within 12 weeks of enrolment, including "anti-inflammatory" strategies (e.g. anti-TNFα, anti-IL-1 RA). Hypersensitivity to: ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID). medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib. Pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males). Additional exclusion criteria specific for US centre.