patients who have received pancreatic islet transplantation
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
Other de
Sponsors
Dompé s.p.a.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients enrolled and treated with reparixin in the REP0110 study. 2. Patients with a functioning graft at last follow-up visit (stimulated serum C-peptide levels > 0.3 ng/mL derived from the MMTT). 3. Patients willing and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations. 4. 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Are the trial subjects under 18?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 3 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: not applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this extension study is to evaluate whether treatment with reparixin at the time of islet transplantation improves long-term outcome of pancreatic islets allotransplantation;Secondary Objective: not applicable;Primary end point(s): Efficacy endpoints will be: The proportion of insulin-independent patients following islet cell transplantation [time frame: month 24, 36 after the last transplant]. Total time of insulin independence after the transplant [time frame: up to 3 years after the last transplant]. Change in average daily insulin requirements (absolute and % decrease from pretransplant levels) [time frame: month 24, 36 after the last transplant]. Glycated hemoglobin (HbA1c) (absolute and % decrease from pre-transplant levels) [time frame: month 24, 36 after the last transplant]. The proportion of patients free of severe hypoglycaemic events [time frame: month 24, 36 after the last transplant]. Basal (2 basal samples in the range between -20 to 0) to 120 min time course of glucose, C-peptide and insulin derived from the mixed meal tolerance test (MMTT) [time frame: month 24, 36 after the last transplant]. ß-cell function as assessed by ß-score and Transplant Estimated Function (TEF) [time frame: month 24, 36 after the last transplant]. Safety endpoints will be: Incidence of serious adverse events (SAEs) [time frame: up to 3 years after the last transplant]. Exploratory endpoints: Auto-antibodies (GAD, IA-2, IAA, ZnT8) [time frame: month 24, 36 after the last transplant]. Anti-HLA antibodies (optional) [time frame: month 24, 36 after the last transplant].;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Italy
Contacts
Public ContactDevelopment Project Manager
Dompé s.p.a.
Outcome results
None listed