FAMODREP : Interest of Famotidine in Reducing Endothelial Expression of P-selectin in Children With Sickle Cell Disease: Pilot Study, Single-center, Prospective, Non-comparative - APHP201133

Assistance Publique Hopitaux De Paris0 个研究点目标入组 30 人2022年11月3日

概览

2022-502144-12-00_RESULTATS-EC_20231122_FAMODREP

注册库

who.int

开始日期

2022年11月3日

结束日期

2022年12月12日

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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 XML File Identifier: DB4LUVFyBpLmaU7F8LN/rGiD0kI\= Page 10/21 sickle cell syndrome SS or Sß0, having at least one vaso\-occlusive crisis in the year prior to inclusion, for young girls of childbearing age (\= 15 years): a negative pregnancy test, 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)

•treatment with crizanlizumab (anti\-P\-selectin antibody), participation in another interventional research involving the human person, bone marrow transplant or gene therapy project within one month of inclusion, 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, pregnancy or breastfeeding