Reparixin in pancreatic islet transplantatio
- Conditions
- Therapeutic area: Diseases [C] - Hormonal diseases [C19]Pancreatic islet transplantationMedDRA version: 17.0Level: PTClassification code 10058846Term: Pancreas islet cell transplantSystem Organ Class: 10042613 - Surgical and medical procedures
- Registration Number
- EUCTR2011-006201-10-CZ
- Lead Sponsor
- Dompé s.p.a.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
1. Ages 18-70 years, inclusive.
2. Patients eligible for a 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 (<0.3 ng/mL) stimulated (arginine or MMTT) C-peptide levels.
Sites will comply with any additional or more stringent criteria locally accepted, as per centre practice.
3. Planned intrahepatic islet transplantation alone from a non-living donor with brain death.
4. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
5. 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
1. Recipients of any previous transplant, including recipients of previous pancreatic islet transplantation.
2. Recipients of islet from a non-heart beating donor.
3. Pre-transplant average daily insulin requirement >1 IU/kg/day.
4. Pre-transplant (the more recent value obtained within the 4 months prior to enrolment) HbA1c >11%.
5. Patients with inadequate renal reserve as per calculated creatinine clearance (CLcr) < 60 mL/min according to the Cockcroft-Gault formula (1976). Should the Investigator suspect this formula is biasing CLcr
estimate, another more accurate GFR measurement (e.g MAG3 or DTPA radioisotope scan, 24 hrs inuline clearance, etc.) may be used.
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]).
Patients with Gilbert's syndrome (elevated unconjugated bilirubin levels in the absence of any evidence of hepatic or biliary tract disease) are not excluded.
7. Patients who receive treatment for a medical condition requiring chronic use of systemic steroids, except for the use of <5mg prednisone daily or equivalent dose of hydrocortisone, for physiological replacement
only.
8. Treatment with any anti-diabetic medication other than insulin within 4 weeks of transplant, apart from the GLP-1 agonists (e.g. exenatide or liraglutide) which will be discontined at least 2 weeks prior to
transplant.
9. Use of any investigational agent within 12 weeks of enrolment, including anti-inflammatory strategies (e.g. anti-TNFa, anti-IL-1 RA).
10. Hypersensitivity to:
a) ibuprofen or to more than one non steroidal anti-inflammatory drug (NSAID).
b) more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone (e.g. sulfamethoxazole) does not qualify for exclusion
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).
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 type 1diabetes (T1D) patients. The safety of reparixin in the specific clinical setting will be also evaluated.;Secondary Objective: N/A;Primary end point(s): Area Under the Curve (AUC) for the serum C-peptide level during the first 2 hours of an MMTT, normalized by the number of Islet Equivalent (IEQ)/kg;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
- Secondary Outcome Measures
Name Time Method