Interest of Famotidine in Children With Sickle Cell Disease (NCT05084521) | Clinical Trial Compass
CompletedPhase 2/3
Interest of Famotidine in Children With Sickle Cell Disease
France30 participantsStarted 2022-01-12
Plain-language summary
The purpose of this study is to determine whether oral famotidine, a histamine type 2 receptor antagonist already widely used with very few side effects in other indications in children, is effective in reducing endothelial expression of P-selectin in children with sickle cell disease (SCD).
This pilot study will constitute the essential prerequisite for a randomized clinical trial comparing the efficacy of famotidine with that of placebo in the prevention of vaso-occlusive crises in SCD patients.
Who can participate
Age range1 Year – 17 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* child or adolescent aged 1 year to 17 years and 10 months, followed at the Necker-Enfants malades Hospital for a SS or Sβ0 SCD;
* having at least one vaso-occlusive crisis in the year prior to inclusion;
* for young girl of childbearing age (≥ 15 years old), a negative pregnancy test;
* signed informed consent of the 2 parents or legal representative(s) and of the child of expressive age or the adolescent;
* beneficiary of social security coverage or entitled (excluding AME)
Exclusion Criteria:
* 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 (ALT ≥ 3N);
* neutropenia (\<1 G/L), thrombocytopenia (\<80 G/L), reticulopenia (\<80 G/L);
* predictable poor adherence to treatment;
* pregnancy or breastfeeding;
* participation in another interventional research involving the human person;
* planned bone marrow transplant or gene therapy within one month of inclusion.
Within 3 months prior to inclusion:
* red blood cell transfusion;
* introduction of hydroxyurea or modification of hydroxyurea doses;
* introduction of L-glutamine or modification of L-glutamine doses;
* introduction of voxelotor or modification …
What they're measuring
1
Difference in plasma concentration of soluble P-selectin