Pancreatic islet transplantation MedDRA version: 17.0 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: DF1681Y
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: reparixin
CAS Number: 266359-83-5
Current Sponsor code: DF1681Y
Other desc
Sponsors
Dompé s.p.a.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 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) 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of insulin-independent patients • The proportion of patients who achieve and maintain an HbA1c 2%) AND are free of severe hypoglycaemic events • The proportion of patients receiving a 2nd islet infusion • Cumulative number of severe hypoglycaemic events • Change in average daily insulin requirements (absolute and % decrease from pre-transplant levels) • HbA1c % (absolute and % decrease from pre-transplant levels) • Basal (fasting) and 0 to 120 min time course of glucose, C-peptide and insulin derived from the MMTT • ß-cell function as assessed by ß-score and Transplant Estimated Function (TEF) ;Timepoint(s) of evaluation of this end point: [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion]. [day 365+/-14 after the last islet infusion]. [day 365+/-14 after the 1st islet infusion]. [day 365+/-14 after the last islet infusion]. [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion]. [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion]. [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion]. [day 75+/-5 after the 1st and 2nd islet infusion and day 365+/-14 after last islet infusion]. | — |
Countries
Czech Republic, Italy, Sweden, United Kingdom, United States
Contacts
Public ContactMargui Chia
Worldwide Clinical Trials Limited
Outcome results
None listed