EUCTR2021-001351-13-FR进行中（未招募）1 期
Interest of famotidine in reducing endothelial expression of P-selectin in children with sickle cell disease: pilot study, single-center, prospective, non-comparative - FAMODREP
Assistance Publique des Hôpitaux de Paris(AP-HP)0 个研究点目标入组 30 人开始时间: 2021年9月9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
- 30
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
- •- child or adolescent aged from 1 year to at most 17 years and 10 months, followed at the Necker-Enfants Malades Hospital for a major sickle cell syndrome SS or Sß0;
- •- having at least one vaso-occlusive crisis in the year prior to inclusion;
- •- signed informed consent of the 2 parents or legal representative (s), and, oral and if possible signed consent of the child of expressive age or the adolescent;
- •- beneficiary of social security coverage or entitled (excluding SMA)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- treatment with crizanlizumab (anti-P-selectin antibody);
- •- treatment with atazanavir / ritonavir in combination with tenofovir;
- •- known hypersensitivity to famotidine or to other histamine type 2 (H2) receptor antagonists;
- •- cardiovascular history such as: arrhythmia, AVB (atrioventricular block), QT prolongation;
- •- Renal failure characterized by creatinine clearance <60 mL / min;
- •- hepatic cytolysis (ALAT = 3N)
- •- neutropenia (<1 G / L), thrombocytopenia (<80 G / L), reticulopenia (<80 G / L);
- •- predictable poor adherence to treatment;
- •- participation in another interventional research involving the human person.
- •- bone marrow transplant or gene therapy project within one month of inclusion
- •Within 3 months prior to inclusion:
- •- erythrocyte transfusion;
- •- introduction of hydroxyurea or modification of the doses of hydroxyurea;
- •- introduction of L-glutamine or modification of the doses of L-glutamine;
- •- introduction of voxelotor or modification of voxelotor doses;
- •- taking oral or IV corticosteroids or any other immunomodulatory treatment;
- •- taking an antihistamine treatment.
- •In the month preceding inclusion:
- •- occurrence of a vaso-occlusive crisis, acute chest syndrome or any vaso-occlusive phenomenon (acute splenic sequestration, priapism, stroke, occlusion of the central retinal artery, papillary necrosis);
- •- occurrence of fever (=38 ° C) or any infectious episode, febrile or not, suspected or confirmed, of a viral, bacterial, fungal or parasitic nature;
- •- occurrence of an acute hemolytic episode (increase in jaundice and pallor, decrease in hemoglobin = 1g / dL compared to baseline hemoglobin, increase in LDH and / or AST and / or free bilirubin deemed significant by the child's referring physician).
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