EUCTR2011-006201-10-CZ进行中（未招募）1 期
A phase 3, multicenter, randomized, double-blind, parallel assignment study to assess the efficacy and safety of reparixin in pancreatic islet transplantation
Dompé s.p.a.0 个研究点目标入组 42 人开始时间: 2012年5月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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 18-70 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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
排除标准
- •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
- •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).
研究者
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