Study to Assess Efficacy & Safety of Reparixin in Pancreatic Islet Transplantation

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this clinical trial was:

• to assess whether Reparixin leads to improved transplant outcome as measured by glycaemic control following intra-hepatic infusion of pancreatic islets in patients with Type 1 diabetes (T1D). The safety of Reparixin in the specific clinical setting was also evaluated.

Background: The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after organ transplantation. Reparixin is the first low molecular weight blocker of CXCL8 biological activity in clinical development. Thus, the use of reparixin may emerge as a potential key component in the sequentially integrated approach to immunomodulation and control of non specific inflammatory events surrounding the early phases of pancreatic islet transplantation in T1D patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dompé Farmaceutici S.p.A

Criteria

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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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:

1. ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID).

2. 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.