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FACA Syrup clinical trial Phase II

Phase II open, controlled and randomized clinical trial of Faca® pediatric syrup for the management of children with sickle cell disease from 06 months to 5 years of age

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603500795589
Enrollment
108
Registered
2026-03-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Diseases

Interventions

FACA syrup

Sponsors

Institut de Recherche en Sciences de la Sante
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Be sickle cell anemia major (SS); ? Must be free of kidney or liver disease ? Must be at least 06 months and no more than 4 years of age, and whose parents or guardians have signed an informed consent form; ? Be able to take the drug orally; ? Reside in the study area (Ouagadougou). ? Available for 3 months ? Not in a sickle-cell disease management program. ? No infectious complications (osteomyelitis

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Significant reduction in seizure frequency/year compared with the control group: at each follow-up visit, the number of seizure episodes will be counted: whether or not these episodes resulted in consultations

Secondary

MeasureTime frame
- Decrease in severity of seizures when they occur - Hematological recovery (increased hemoglobin levels, inhibition of red blood cell falciformation).

Countries

Burkina Faso

Contacts

Public ContactGeoffroy Gueswinde OUEDRAOGO

Researcher at Institut de Recherche en Sciences de la Sante

guioffray@gmail.com0022670091503

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026