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Completed

NCT Number: NCT05279924

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

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

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

2 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Yopougon

Abidjan, Côte d’Ivoire

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

severe hemophilia A with or without inhibitors -

Exclusion criteria

parents refusal

-

Treatment and study plan

Prophylaxis with Emicizumab

Drug

Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

Primary outcomes

  1. Change in annual bleeding rate

    Time frame: change in annual bleeding rate from baseline at 6 months and 12 months

    Using the patients' logbook

  2. Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D in children treated with Emicizumab

    Time frame: 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

  3. Satisfaction of the parents about the treatment with Emicizumab after 6 month

    Time frame: Assessment at 6 months after initiation of Emicizumab

    Usign the PGIC (scale ranging from extremely satisfied to extremely unsatisfied)

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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