Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab (NCT05802836) | Clinical Trial Compass
RecruitingNot Applicable
Dynamics of the Anti-factor VIII Antibody Signature During Treatment With Emicizumab
Germany100 participantsStarted 2023-04-26
Plain-language summary
The goal of this observational study is to learn about the changes of antibodies and inhibitors against the coagulation factor VIII in patients with severe hemophilia A receiving emicizumab therapy. No additional visits or procedures are planned. Patients in this study will continue to receive their routine care and analysis will be done from left over samples from routine visits.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Severe congenital hemophilia A (CHA)
* Treatment with emicizumab irrespective of any other treatment
* Informed consent
Exclusion Criteria:
* No therapy with emicizumab
* Immunosuppressive therapy
* HIV-infection with CD4 (cluster of differentiation 4) cells \<200/µl
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
FVIII inhibitor development in inhibitor negative subjects
Timeframe: 3 years
2
FVIII antibody development in inhibitor negative subjects
Timeframe: 3 years
3
FVIII inhibitor disappearance in inhibitor positive subjects
Timeframe: 3 years
4
FVIII antibody disappearance in inhibitor positive subjects