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ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
NCT04398628 · View on ClinicalTrials.gov ↗
Study Summary
In parallel with the growth of ATHN's clinical studies, the number of new therapies for all blood disorders is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have not yet demonstrated long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.2,3,4,5 In 2019 alone, the FDA has issued approvals for 24 new therapies for congenital and acquired hematologic conditions.6 In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.7 With this increase in potential new therapies possible, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.8
Conditions Studied
Study Locations (20)
California
- Orthopaedic Institute for Children HTC — Los Angeles
- Childrens Hospital Los Angeles — Los Angeles
- UCSF Benioff Children's Hospital Oakland — Oakland
- University of California at Davis Hemophilia Treatment Center — Sacramento
- Loma Linda Hemoglobinopathy and Inherited Bleeding Disorder Program — San Bernardino
- Hemophilia & Thrombosis Treatment Center at UC San Diego Health — San Diego
- Rady Children's Hospital San Diego — San Diego
- University of California, San Francisco Hemophilia & Thrombosis Center — San Francisco
Florida
- University of Florida Hemophilia Treatment Center — Gainesville
- University of Miami Comprehensive Hemophilia Treatment Center — Miami
- Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders — Orlando
- Johns Hopkins All Children's Hospital — St. Petersburg
- St. Joseph's Hospital Center for Bleeding & Clotting Disorders — Tampa
Connecticut
- Connecticut Children's Medical Center — Hartford
- Yale Hemophilia Treatment Center — New Haven
District of Columbia
- Georgetown University — Washington D.C.
- Children's National Hemophilia Center — Washington D.C.
Arizona
- Arizona Hemophilia and Thrombosis Treatment Center at Phoenix Children's Hospital — Phoenix
Arkansas
- Arkansas Center for Bleeding Disorders — Little Rock
Delaware
- Delaware Hemophilia Treatment Center — Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2020-09-30 |
| Est. Completion | 2035-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04398628
The ClinicalTrials.gov registry entry for NCT04398628 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Thrombosis and Hemostasis Network, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Thrombosis appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04398628 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04398628 about?
NCT04398628 is a clinical study titled "ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders". In parallel with the growth of ATHN's clinical studies, the number of new therapies for all blood disorders is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have not yet demonstrated long-term safety and effectiveness beyond ...
What is the current status of trial NCT04398628?
This trial is currently recruiting. The enrollment target is 3,000 participants. The study started on 2020-09-30. Estimated completion is 2035-12.
What conditions does trial NCT04398628 study?
This clinical trial studies the following conditions: Thrombosis, Hemophilia, Von Willebrand Diseases, Bleeding Disorder, Thrombophilia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04398628?
This trial is sponsored by American Thrombosis and Hemostasis Network, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04398628 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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