E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pancreatic islet transplantation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058846 |
E.1.2 | Term | Pancreas islet cell transplant |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this clinical trial is to evaluate whether reparixin leads to improved transplant outcome as measured by glycaemic control following a single-donor intra-hepatic infusion of pancreatic islets. The safety of reparixin in the specific clinical setting will be also evaluated. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged 18-65 years with a clinical history of type 1 diabetes (T1D) for >=5 years and undetectable stimulated C-peptide who are eligible for pancreatic islet transplantation (planned intra-hepatic islets transplantation from non-living donor with brain death; planned infusion of 4000 to 7000 islet equivalent (IEQ)/kg body weight) and have given written informed consent will be included. Patient must have an adequate renal reserve as per calculated creatinine clearance (CLcr) >=60 mL/min (Cockcroft-Gault formula). |
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E.4 | Principal exclusion criteria |
Patients will be excluded if they are recipients of any previous transplant (except from recipient of a previuos pancreatic islet transplantation that has failed, are off immunosuppression for >= 1 year and have no anti-HLA antibodies); have a body mass index (BMI) of > 30kg/m2; have an insulin requirement of > 1 IU/kg/day; have a glycated hemoglobin (HbA1c) of > 10%. Patients with abnormal liver function tests (ALT/AST > 3 x upper limit of normal (ULN) and total bilirubin > 3mg/dL [> 51.3 μmol/L]); who receive chronic systemic steroids; are treated with any anti-diabetic medication other than insulin or with investigational agents within 4 weeks of transplant; have hypersensitivity to ibuprofen or to more than one non-steroidal anti-inflammatory drug or to sulfonamides will be excluded as well. Pregnant or breast-feeding women or males and females unwilling to use effective contraceptive measures will also be excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
evaluate whether reparixin leads to improved transplant outcome as measured by glycaemic control following a single-donor intra-hepatic infusion of pancreatic islets |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
valutazione del meccanismo d`azione |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
no experimental treatment |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
ultima visita dell`ultimo paziente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |