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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05279924

Enrollment

Registered

2022-03-15

Start date

2021-07-01

Completion date

2022-10-20

Last updated

2022-10-26

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

Conditions

Hemophilia A

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).

Interventions

DRUGProphylaxis with Emicizumab

Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

Eligibility

Sex/Gender

MALE

Age

2 Years to 18 Years

Healthy volunteers

Inclusion criteria

severe hemophilia A with or without inhibitors -

Exclusion criteria

parents refusal \-

Design outcomes

Primary

Measure	Time frame	Description
Change in annual bleeding rate	change in annual bleeding rate from baseline at 6 months and 12 months	Using the patients' logbook
Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D in children treated with Emicizumab	Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D at 6 months.	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
Satisfaction of the parents about the treatment with Emicizumab after 6 month	Assessment at 6 months after initiation of Emicizumab	Usign the PGIC (scale ranging from extremely satisfied to extremely unsatisfied)

Countries

Côte d’Ivoire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026