rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A (NCT03951103) | Clinical Trial Compass
CompletedNot Applicable
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
France, Germany, Ireland44 participantsStarted 2018-11-07
Plain-language summary
A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.
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:
* Patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI.
* Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, before any study-related data collection are undertaken. Assent should be obtained from paediatric patients according to local regulations.
Exclusion Criteria:
* Current participation in any investigational medicinal product trial.
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
ITI with rFVIIIFc: Main dose
Timeframe: From 2018 to 2022
2
ITI with rFVIIIFc: Main injection frequency
Timeframe: From 2018 to 2022
3
ITI with rFVIIIFc: Duration
Timeframe: From 2018 to 2022
4
ITI with rFVIIIFc: Concomitant by-passing agents
Timeframe: From 2018 to 2022
5
Outcome of ITI with rFVIIIFc: Overall outcome
Timeframe: From 2018 to 2022
6
Outcome of ITI with rFVIIIFc: Time to undetectable inhibitor titer
Timeframe: From 2018 to 2022
7
Outcome of ITI with rFVIIIFc: Time to normal recovery