intrahepatic islet transplantation MedDRA version: 14.0 Level: PT Classification code 10058846 Term: Pancreas islet cell transplant System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Reparixin
Product Code: DF 1681Y
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Reparixin
CAS Number: 266359-83-5
Current Sponsor code: DF 1681Y
Concentr
Sponsors
Dompé s.p.a.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ages 18-65 years, inclusive. 2. Patients eligible for pancreatic islet transplantation program based on local accepted practice and guidelines. This includes at least: - clinical history compatible with T1D with insulin-dependence for >= 5 years; - undetectable stimulated (arginine or MMTT) C-peptide levels (= 60 mL/min according to the Cockcroft-Gault formula (1976). 4. Planned intrahepatic islet transplantation alone from a non-living donor with brain death. 5. Planned first infusion of 4000 to 7000 islet equivalent (IEQ)/kg body weight. 6. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations. 7. Patients 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Recipients of any previous transplant, except from recipients of a previous pancreatic islet transplantation that has failed, are off immunosuppression since at least 1 year and have negative anti-HLA. 2. Recipients of islet from a non-heart beating donor. 3. A body mass index >30 kg/m2 or patient weight 1 IU/kg/day 5. Pre-transplant HbA1c >10%. 6. Patients with hepatic dysfunction as defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3mg/dL [>51.3 µmol/L]). 7. Patients who receive treatment for a medical condition requiring chronic use of systemic steroids 8. Treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant 9. Use of any investigational agent within 4 weeks of enrolment 10. Hypersensitivity to: a) ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID). b) medications belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib. 11. Pregnant or breast-feeding women; unwillingness to use effective contraceptive measures (females and males). (NB: pregnancy should be avoided in patients or partners during the first month after each treatment with the Investigational Product; no other specific warnings are described, considering even stricter general recommendations concerning pregnancy in transplanted patients, the treatment course of the Investigational Product, its PK profile, and the lack of significant adverse effects on mating performance and fertility in animal studies).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this clinical trial is to evaluate whether CXCL8 inhibition with reparixin leads to improved functional and clinical outcome in intrahepatic islet transplantation patients. The safety of reparixin in the specific clinical setting will be also evaluated.;Secondary Objective: Not applicable;Primary end point(s): evaluate 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: 14 or more consecutive days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Germany, Italy
Contacts
Public ContactProject Development Director
Dompé s.p.a.
Outcome results
None listed