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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Hemophilia A

Treatments: Drug: Prophylaxis with Emicizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05279924

001-22/MSHPCMU/CNESVS-km

Details and patient eligibility

About

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

Full 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).

Enrollment: 33 patients

Sex: Male

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: severe hemophilia A with or without inhibitors -

Exclusion Criteria: parents refusal

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Ivoirian Boys with severe Hemophilia A treated with Emicizumab

Experimental group

Description:

All Ivoirian boys with severe Hemophilia A (with and without inhibitors) on prophylaxis with Emicizumab

Treatment:

Drug: Prophylaxis with Emicizumab