EUCTR2010-019424-31-DE进行中（未招募）不适用
A phase 2 multicenter, randomized, open label, parallel assignment, pilot study to assess the efficacy and safety of reparixin following islet transplantation in patients with type 1 diabetes mellitus - Reparixin following islet transplantation
Dompé s.p.a.0 个研究点目标入组 10 人开始时间: 2010年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 (<0.3 ng/mL) evidenced at any time before transplant.
- •Sites will comply with any additional or more stringent criteria locally accepted, as
- •per centre practice.
- •3. Patients with adequate renal reserve as per calculated creatinine clearance (CLcr) >= 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
排除标准
- •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 <= 45 kg
- •4. Pre-transplant average daily insulin requirement >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
- •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).
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