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NCT05279924 Clinical Trial

Outcomes of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast

Hemophilia A Clinical Trial

Official title:
Impact of Implementation of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05279924
Other study ID # 001-22/MSHPCMU/CNESVS-km
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date October 20, 2022

Study information
Verified date October 2022
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast

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).

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date October 20, 2022
Est. primary completion date October 20, 2022
Accepts healthy volunteers No
Gender Male
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria: severe hemophilia A with or without inhibitors - Exclusion Criteria: parents refusal -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prophylaxis with Emicizumab
Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

Locations
Country Name City State
Côte D'Ivoire CHU de Yopougon Abidjan

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Côte D'Ivoire, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in annual bleeding rate Using the patients' logbook change in annual bleeding rate from baseline at 6 months and 12 months
Primary Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D in children treated with Emicizumab Using the CHO-KLAT and EQ-5D. The scales range from 0 to 100 with 0 representing the worst quality of life and 100 the best quality of life score Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D at 6 months.
Primary Satisfaction of the parents about the treatment with Emicizumab after 6 month Usign the PGIC (scale ranging from extremely satisfied to extremely unsatisfied) Assessment at 6 months after initiation of Emicizumab
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