Hemophilia ANCT05279924
Outcomes of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast
A study testing Prophylaxis with Emicizumab in people with Hemophilia A, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Côte d’Ivoire.
Trial summary
Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast Read more about this study
- Who is it for?
- Ages 2 to 18 years, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Prophylaxis with Emicizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 1 Jul 2021to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Hemophilia A
- Being tested
- Prophylaxis with Emicizumab
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylaxis with EmicizumabDrug
Prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Prophylaxis with Emicizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in annual bleeding rate
Using the patients' logbook
Measured: 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
Measured: 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)
Measured: Assessment at 6 months after initiation of Emicizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Jul 2021
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lambert Catherine, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- N'Dogomo Meité, MD, Principal investigator, CHU de Cocody
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279924
- Sponsor's protocol ID
- 001-22/MSHPCMU/CNESVS-km
- Status last verified
- Oct 2022
- First submitted
- 25 Feb 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implementation of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast
- ClinicalTrials.gov ID
- NCT05279924
- Acronym / sponsor ID
- 001-22/MSHPCMU/CNESVS-km
- Conditions
- Hemophilia A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
| Arm | Type | Receives |
|---|---|---|
| Ivoirian Boys with severe Hemophilia A treated with Emicizumab | Experimental | Drug: Prophylaxis with EmicizumabAll Ivoirian boys with severe Hemophilia A (with and without inhibitors) on prophylaxis with Emicizumab |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prophylaxis with EmicizumabProphylaxis with Emicizumab in Ivoirian boys with severe hemophilia A | Drug | Ivoirian Boys with severe Hemophilia A treated with Emicizumab |
Primary outcome
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 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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
N'Dogomo Meité, MD principal investigator
CHU de Cocody
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prophylaxis with Emicizumab in people with Hemophilia A, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in annual bleeding rate (time frame: change in annual bleeding rate from baseline at 6 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.