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FAMODREP : Interest of Famotidine in Reducing Endothelial Expression of P-selectin in Children With Sickle Cell Disease: Pilot Study, Single-center, Prospective, Non-comparative
EU CTIS ID: 2022-502144-12-00
What this study is testing
To assess the effect of famotidine on P-selectin expression after 29 days of treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 Sβ0
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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 Sβ0
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.