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2021年9月9日

概览

暂无简介。

注册库

who.int

开始日期

2021年9月9日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Assistance Publique des Hôpitaux de Paris(AP-HP)

•\- 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

•\- 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