NCT05702996撤回3 期
Multicenter, Uncontrolled Pilot Study Evaluating the Efficacy of Eculizumab in the Treatment of Gemcitabine-induced Thrombotic Microangiopathies
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Time from initiation of eculizumab treatment to renal remission
研究概览
简要总结
The main objective of this prospective multisite trial is to study the evolution of TMA (thrombotic microangiopathy) induced by gemcitabin and treated by eculizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age ≥ 18 years old
- •Previous treatment with gemcitabine within the last 18 months (duration of treatment ≥ 3 consecutive months and cumulative dose should be ≥ 10 grams).
- •Neoplasia in remission or not in remission but with an estimated life expectancy > 6 months
- •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.
- •Clinical and biological criteria for thrombotic microangiopathy: mechanical hemolytic anemia and/or tThrombocytopeniaPatient affiliated with a social security system,
- •Adult patient or representative of the adult patient who has read and understood the information letter and signed the consent form.
- •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
排除标准
- •1. Progressive neoplasia with a life expectancy of <6 months
- •Patient with a contraindication to the administration of the treatment experienced: SOLIRIS® 300 mg concentrate for solution for infusion
- •Contraindication to antibiotic prophylaxis
- •Thrombotic microangiopathy associated with cancer (metastatic adenocarcinoma with bone marrow invasion, erythromyelemia, disseminated intravascular coagulation)
- •Active systemic bacterial infection, untreated or confirmed sepsis (positive blood cultures within 7 days of patient inclusion and not treated with effective antibiotic therapy)
- •Unresolved meningococcal infection
- •Patient not vaccinated against meningococcal infection
- •Pregnant or breastfeeding woman or proven lack of contraception
- •Known systemic lupus erythematosus
- •Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship
- •Patient participating in another interventional clinical trial / having participated in another interventional clinical trial within 1 month
研究组 & 干预措施
Patient with Thrombotic microangiopathies induced by gemcitabine
Experimental
Patient with Thrombotic microangiopathies induced by gemcitabine will be treat with Eculizumab
干预措施: Eculizumab administration (Drug)
结局指标
主要结局
Time from initiation of eculizumab treatment to renal remission
时间窗: maximum 12 months
次要结局
- Number of AE and SAE during the study(12 months)
- Number of red blood cells transfused before and after treatment with eculizumab(12 months)
研究者
研究点 (2)
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