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

NCT ID: NCT05279924

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-10-20

Brief Summary

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

Detailed Description

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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).

Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ivoirian Boys with severe Hemophilia A treated with Emicizumab

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

Group Type EXPERIMENTAL

Prophylaxis with Emicizumab

Intervention Type DRUG

Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

Interventions

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Prophylaxis with Emicizumab

Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Lambert Catherine

Clinical Professor. Hematology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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N'Dogomo Meité, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Cocody

Locations

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CHU de Yopougon

Abidjan, , Côte d’Ivoire

Site Status

Countries

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Côte d’Ivoire

Other Identifiers

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001-22/MSHPCMU/CNESVS-km

Identifier Type: -

Identifier Source: org_study_id

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