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

October 24, 2022 updated by: Lambert Catherine, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Impact of Implementation 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria: severe hemophilia A with or without inhibitors -

Exclusion Criteria: parents refusal

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ivoirian Boys with severe Hemophilia A treated with Emicizumab
All Ivoirian boys with severe Hemophilia A (with and without inhibitors) on prophylaxis with Emicizumab
Drug: Prophylaxis with Emicizumab
Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in annual bleeding rate
Time Frame: change in annual bleeding rate from baseline at 6 months and 12 months
Using the patients' logbook
change in annual bleeding rate from baseline at 6 months and 12 months
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
Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D at 6 months.
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)
Assessment at 6 months after initiation of Emicizumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: N'Dogomo Meité, MD, CHU de Cocody

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

March 5, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-22/MSHPCMU/CNESVS-km

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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