Status:
UNKNOWN
Health-Related Quality of Life Outcomes and Bleeding Rates Among Patients With Severe Hemophilia A on Emicizumab
Lead Sponsor:
Newark Beth Israel Medical Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Hemophilia A
Eligibility:
All Genders
4+ years
Brief Summary
The main purposes of this study are to determine if use of emicizumab prophylaxis treatment reduces number of bleeding episodes, if it improves quality of life of individuals and if improves arthropat...
Detailed Description
The main purpose of this study is to determine if use of emicizumab prophylaxis treatment reduces number of bleeding episodes and if it affects quality of life of individuals with hemophilia. Patient...
Eligibility Criteria
Inclusion
- Inclusion Criteria Part A: ABR
- Signed Informed Consent/Assent Form
- Age 4 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Diagnosis of hemophilia A (any severity) on emicizumab or factor concentrate prophylaxis for at least 12 months each
- Plan to be adherent to emicizumab prophylaxis during the study
- Patient with inhibitors
- Patient without inhibitors Part B: HRQoL and Arthropathy
- Signed Informed Consent/Assent Form
- Age 4 years at time of signing Informed Consent Form
- Ability to comply with the study protocol, in the investigator's judgment
- Diagnosis of hemophilia A (any severity) who has decided to switch to emicizumab prophylaxis
- Plan to be adherent to emicizumab prophylaxis during the study
- Individuals of childbearing age will be included in this study. Their participation involves voluntary completion of a questionnaire. There are no additional precautions required for this population.
- Patient/parent must be able to read and write English/Spanish
- Exclusion Criteria:
- Part A: ABR
- Patients who are on a clinical trial for prophylaxis
- Patients with other bleeding disorders needing any scheduled treatment
- No eligibility restrictions will be based on gender, race, ethnic background or economic status
- Part B: HRQoL and Arthropathy
- Patients who are on a clinical trial for prophylaxis
- Patients with other bleeding disorders needing any scheduled treatment
- Patients/parents who refuse to complete questionnaire or have joint health assessment by HJHS
- No eligibility restrictions will be based on gender, race, ethnic background or economic status
Exclusion
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06104826
Start Date
December 1 2023
End Date
December 1 2025
Last Update
October 30 2023
Active Locations (1)
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1
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112