FACA Syrup clinical trial

Phase 1

• Conditions: Genetic Diseases; Paediatrics

• Registration Number: PACTR202407870029422
• Lead Sponsor: Institut de Recherche en Sciences de la Sante

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Must not have sickle cell disease or sickle cell trait (hemoglobin AA on electrophoresis);
No renal or hepatic impairment;
Must be at least 06 months and no more than 57 months old;
Parents or guardians in charge of the child who have signed the informed consent form;
Be able to take FACA® Pediatric Syrup orally;
Reside in the study area (Ouagadougou)

Exclusion Criteria

Known allergies to study drugs or any of their components;
Participation in any other ongoing clinical study
Participant undergoing another treatment for sickle cell disease at the time of the trial;
Refusal to sign informed consent by parents or guardians;
Participant presenting signs of severity (chronic complications, stroke, acute chest syndrome, etc.).
Participant with severe neurological and/or mental disorders;
Patient suffering from any other serious pathologies

Study & Design

• Study Type: Interventional
• Study Design: Not specified