A Study to Evaluate Seroprevalence and Seroconversion of Antibodies to Adeno-Associated Virus (AA… (NCT04560933) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate Seroprevalence and Seroconversion of Antibodies to Adeno-Associated Virus (AAV) in Patients With Hemophilia A
United States186 participantsStarted 2020-08-25
Plain-language summary
To quantify the seroprevalence of antibodies to AAV5, AAV6, and AAV8 and the seroconversion rate over varying follow-up intervals in subjects with hemophilia A
Who can participate
Age range
18 Years
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:
* Subjects diagnosed with Hemophilia A
* Subjects aged 18years or over at time of entry
Exclusion Criteria:
* Currently participating in an interventional study of any investigational product, device or procedure.
* Subjects who have been previously treated with AAV vector gene therapy
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.
1Since this study looked at how many hemophilia A patients already have antibodies to AAV vectors, could you check whether I have those antibodies, and what that would mean for my eligibility if I were ever interested in an AAV-based gene therapy?
2I understand this study is now completed — has the seroprevalence data it collected been published, and can you share what it found about how common AAV antibodies are in people with hemophilia A?
3Because AAV antibodies can develop over time even without gene therapy exposure, is it worth monitoring my AAV antibody levels periodically so we have that information on hand if a gene therapy option becomes relevant later?
4This was an observational study measuring antibody levels rather than testing a treatment — does that mean its findings would mainly affect which gene therapy trials I might or might not qualify for, rather than changing my current treatment plan?
5Are there AAV gene therapy trials for hemophilia A currently open that we should be thinking about in parallel with reviewing what this seroconversion study found?
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
Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A
Timeframe: Baseline
2
Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A