reparixin in pancreatic islet transplantatio

Phase 1

• Conditions: pancreatic islet transplantation; MedDRA version: 14.1Level: PTClassification code 10058846Term: Pancreas islet cell transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2011-006201-10-IT
• Lead Sponsor: DOMPE' s.p.a.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-08
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Patients aged 18-70 years given written informed consent who are eligible for a pancreatic islet transplantation program [clinical history of T1D with insulin-dependence for >=5 years, undetectable (<0.3 ng/mL) stimulated C-peptide levels] and planned to receive intrahepatic islet transplantation alone from a non-living donor with brain death.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Recipients of any previous transplant (including previous islet transplantation), of islet from a non-heart beating donor will be excluded. Patients who have pre-transplant average daily insulin requirement >1 IU/kg/day, pre-transplant HbA1c >11%, inadequate renal reserve (calculated creatinine clearance < 60 mL/min according to the Cockcroft-Gault formula) or hepatic dysfunction (increased ALT/AST > 3 x upper limit of normal and increased total bilirubin > 3mg/dL) will be excluded as well. Also, patients will be excluded if they receive treatment for a medical condition requiring chronic use of systemic steroids or treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant or any investigational agent within 12 weeks of enrolment. Patients with hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory drug or to medications belonging to the class of sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib) as well as pregnant or breast-feeding women or unwillingness to use effective contraceptive measures (females and males) will be excluded from study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in T1D patients. The safety of reparixin in the specific clinical setting will be also evaluated.;Secondary Objective: ND;Primary end point(s): assess whether reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets;Timepoint(s) of evaluation of this end point: day 75 +/- 5 after the 1st islet infusion and day 365 +/- 14 after the last islet infusion