Efficacy and safety of aprepitant for vaso-occlusive crisis in sickle cell child

Phase 1

Active, not recruiting

• Conditions: vaso-occlusive crisis for patients with sickle cell disease; MedDRA version: 20.0Level: LLTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2019-000839-21-FR
• Lead Sponsor: Centre Hospitalier Intercommunal de Créteil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Child between 6 years (age of possible use of the self-controlled Morphine pump) and 17 years (=6 years and =17 years)
- Any genotype of major sickle cell syndrome (SS, SßThal, SC, SDpunjab)
- Admission to pediatric emergencies for a CVO, excluding an acute splenic sequestration crisis; living at home for less than 48 hours
- Requiring analgesic treatment with Morphine (Pain score = 7/10 on the scale of the faces or = 10/15 on the EVENDOL scale, according to the PEDIADOL recommendations)
- Informed consent signed by parents
- Affiliation to the French social security

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
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

Exclusion Criteria

- Children in the regular transfusion program and children who have received a hematopoietic stem cell transplant
- Child hospitalized at least 5 times for CVO in the 12 months preceding the inclusion (psychic problems making difficult the evaluation of the pain)
- Child who has already been included in the study during a previous CVO (each child participates in the study only once)
- CVO evolving for more than 48 hours before admission to emergency
- Seizure of acute splenic sequestration at admission
- Children with any other pathology resulting from a painful phenotype
- Child with major problems or other problems preventing the self-controlled administration of Morphine
- Pregnancy
- Severe hepatic or renal insufficiency
- Patient with current treatment: pimozide, terfenadine, astemizole, cisapride. ciclosporin, tacrolimus, sirolimus, everolimus, alfentanil, alkaloids derived from ergot of rye, fentanyl and quinidine
- Hypersensitivity to the active substance or to any of the excipients of Emend (including rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency.)
- Ongoing participation in an interventional research RIPH1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified