NCT05279924

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

February 25, 2022

Last Update Submit

October 24, 2022

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (3)

  • Change in annual bleeding rate

    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

    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

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

    Assessment at 6 months after initiation of Emicizumab

Study Arms (1)

Ivoirian Boys with severe Hemophilia A treated with Emicizumab

EXPERIMENTAL

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

Drug: Prophylaxis with Emicizumab

Interventions

Prophylaxis with EmicizumabDRUG

Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A

Ivoirian Boys with severe Hemophilia A treated with Emicizumab

Eligibility Criteria

Age2 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Yopougon

Abidjan, Côte d’Ivoire

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

emicizumab

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • N'Dogomo Meité, MD

    CHU de Cocody

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor. Hematology department

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 15, 2022

Study Start

July 1, 2021

Primary Completion

October 20, 2022

Study Completion

October 20, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CÔ(1)