ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
This study, called ATHN Transcends, is looking at the long-term safety of treatments for various blood disorders, including bleeding disorders like hemophilia, clotting disorders (thrombosis), and connective tissue disorders that cause bleeding. It's an observational study, meaning researchers will collect information about your health and treatments over time, rather than testing a specific new drug. The goal is to understand how well current therapies work and if they have any long-term side effects. You can join if you have a congenital (present from birth) or acquired blood disorder, or if you have unexplained bleeding. The study aims to follow 3,000 participants for at least 15 years. The current recruitment status is unclear.
- Study design
- This is an observational study that will follow about 3,000 participants over time. Participants will be assigned to one of several groups based on their specific blood disorder.
- What's involved
- You will be followed for a minimum of 15 years. Data will be collected when you enroll, every six months, annually, and as needed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for a minimum of 15 years, and potentially longer depending on their specific study arm or module.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
At a glance
Conditions
Where it's being run
76 sites across 31 statesStudy leadership
- Michael Recht, MD, PhD, MBA · PRINCIPAL_INVESTIGATOR · Yale University School of Medicine & National Bleeding Disorders Foundation
- Tammuella Chrisentery-Singleton, MD · PRINCIPAL_INVESTIGATOR · ATHN, Ochsner Clinic Foundation
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- To determine the safety of therapies used in the treatment of participants with congenital or acquired non-neoplastic, bleeding and clotting disorders and connective tissue disorders with bleeding tendency (blood disorders).15 years
Safety will be measured by those events in the European Safety Surveillance (EUHASS)1: 1. Allergic or other acute events 2. Treatment-emergent side effects of therapy 3. Transfusion transmitted infections 4. Inhibitor development 5. Thrombosis 6. Cardiovascular events 7. Malignancies 8. Neurological events 9. Death In addition to the modified EUHASS endpoints, the following events will be collected as adverse events of special interest (AESI): 1. The occurrence of thrombotic microangiopathies, injection site reactions and cases of potential drug-induced liver injury 2. The development of anti-drug antibodies, to be measured and confirmed, if feasible 3. Severe, unanticipated bleeding 4. Hospitalizations 5. Glomerulonephritis 6. Any arm or module-specific AESI as stated in their corresponding Safety Assessment section Additional safety events of interest may be collected.