EUCTR2020-003168-22-FR进行中（未招募）1 期
Multicenter, uncontrolled pilot study evaluating the efficacy of eculizumab in the treatment of gemcitabine-induced thrombotic microangiopathies. - GEMECULI
Rouen University Hospital0 个研究点目标入组 10 人开始时间: 2021年6月1日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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.Age = 18 years old
- •2.Previous treatment with gemcitabine within the last 18 months (duration of treatment = 3 consecutive months and cumulative dose should be = 10 grams).
- •3.Neoplasia in remission or not in remission but with an estimated life expectancy > 6 months
- •4.Acute renal failure defined by 1 of the following 2 criteria : Creatinine > 2 times baseline creatinine and/or diuresis < 0.5 ml/kg/h for 12 hours.
- •5.Clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tThrombocytopeniaPatient affiliated with a social security system,
- •6.Adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form.
- •7.Woman of childbearing age with effective contraception as defined by the WHO (estrogen-progestin or intrauterine device or tubal ligation) for more than one month and a negative -HCG pregnancy test at baseline, for the duration of the study and for at least 5 months after the end of the treatment, or Postmenopausal woman (non-medically induced amenorrhea for at least 12 months prior to the baseline visit) or For men, use of protection during sexual intercourse for the duration of the study and for at least 60 days after the end of study treatment
- •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 0
排除标准
- •1. Progressive neoplasia with a life expectancy of <6 months
- •2. Patient with a contraindication to the administration of the treatment experienced: SOLIRIS® 300 mg concentrate for solution for infusion
- •3. Contraindication to antibiotic prophylaxis
- •4. Thrombotic microangiopathy associated with cancer (metastatic adenocarcinoma with bone marrow invasion, erythromyelemia, disseminated intravascular coagulation)
- •5. Active systemic bacterial infection, untreated or confirmed sepsis (positive blood cultures within 7 days of patient inclusion and not treated with effective antibiotic therapy)
- •6. Unresolved meningococcal infection
- •7. Patient not vaccinated against meningococcal infection
- •8. Pregnant or breastfeeding woman or proven lack of contraception
- •9. Known systemic lupus erythematosus
- •10. Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship
- •11. Patient participating in another interventional clinical trial / having participated in another interventional clinical trial within 1 month
研究者
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