A phase 2 multicenter, randomized, open label, parallel assignment, pilot study to assess the efficacy and safety of reparixin following a single infusion islet transplantation in patients with type 1 diabetes mellitus. - Reparixin in Pancreatic Islet Transplantatio

Conditions: pancreatic islet transplantation
MedDRA version: 12.1Level: LLTClassification code 10058846Term: Pancreas islet cell transplant

Registration Number: EUCTR2010-019424-31-IT

Lead Sponsor: DOMPE` s.p.a.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Patients aged 18-65 years with a clinical history of type 1 diabetes (T1D) for >=5 years and undetectable stimulated C-peptide who are eligible for pancreatic islet transplantation (planned intra-hepatic islets transplantation from non-living donor with brain death; planned infusion of 4000 to 7000 islet equivalent (IEQ)/kg body weight) and have given written informed consent will be included. Patient must have an adequate renal reserve as per calculated creatinine clearance (CLcr) >=60 mL/min (Cockcroft-Gault formula).
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded if they are recipients of any previous transplant (except from recipient of a previuos pancreatic islet transplantation that has failed, are off immunosuppression for >= 1 year and have no anti-HLA antibodies); have a body mass index (BMI) of > 30kg/m2; have an insulin requirement of > 1 IU/kg/day; have a glycated hemoglobin (HbA1c) of > 10%. Patients with abnormal liver function tests (ALT/AST > 3 x upper limit of normal (ULN) and total bilirubin > 3mg/dL [> 51.3 µmol/L]); who receive chronic systemic steroids; are treated with any anti-diabetic medication other than insulin or with investigational agents within 4 weeks of transplant; have hypersensitivity to ibuprofen or to more than one non-steroidal anti-inflammatory drug or to sulfonamides will be excluded as well. Pregnant or breast-feeding women or males and females unwilling to use effective contraceptive measures will also be excluded.