Brief Title
Outcomes of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast
Official Title
Impact of Implementation of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast
Brief Summary
Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast
Detailed Description
Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast. Duration of the study: 1 year after initiation of prophylaxis with Emicizumab Inclusion criteria: boys aged > 2 years, affected with severe hemophilia A with or without inhibitors Evaluated outcomes: annual bleeding rate, days of absence from school, the need for additional facteur VIII consumption, satisfaction about the treatment and quality of life. Tools used to assess quality of life are the Ivoirian version of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool version 2 (CHO-KLAT) and EQ-5D The satisfaction of the parents will be assessed using the patients' global impression of change scale (PGIC).
Study Type
Interventional
Primary Outcome
Change in annual bleeding rate
Condition
Hemophilia A
Intervention
Prophylaxis with Emicizumab
Study Arms / Comparison Groups
Ivoirian Boys with severe Hemophilia A treated with Emicizumab
Description: All Ivoirian boys with severe Hemophilia A (with and without inhibitors) on prophylaxis with Emicizumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
July 1, 2021
Completion Date
July 2022
Primary Completion Date
July 2022
Eligibility Criteria
Inclusion Criteria: severe hemophilia A with or without inhibitors - Exclusion Criteria: parents refusal -
Gender
Male
Ages
2 Years - 18 Years
Accepts Healthy Volunteers
No
Contacts
N'Dogomo Meité, MD, 027641708, [email protected]
Location Countries
Côte D'Ivoire
Location Countries
Côte D'Ivoire
Administrative Informations
NCT ID
NCT05279924
Organization ID
001-22/MSHPCMU/CNESVS-km
Responsible Party
Principal Investigator
Study Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor
N'Dogomo Meité, MD, Principal Investigator, CHU de Cocody
Verification Date
March 2022