Interest of Famotidine in Children With Sickle Cell Disease

NCT05084521 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Famotidine 400 mg/50 mL

Administration of a suspension of famotidine, 0.5 mg/kg/12h (with a maximum dose of 80 mg/day, regardless of the patient's weight) during 29 days.

Sponsors & Collaborators

  • INSERM U 1163 - Laboratory of molecular mechanisms of hematologic disorders and therapeutic implications, Paris

    collaborator UNKNOWN
  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Slimane ALLALI, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Olivier HERMINE, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-12
Primary Completion
2022-12-12
Completion
2022-12-12
FDA Drug
Yes

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05084521 on ClinicalTrials.gov