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NCT03818529 · ClinicalTrials.gov registry record
ATHN 8: Previously Untreated Patients (PUPs) Matter Study
A clinical trial, sponsored by American Thrombosis and Hemostasis Network.
- Completed
- Registry status
- 237
- Enrollment target
NCT03818529: Completed study, sponsored by American Thrombosis and Hemostasis Network.
NCT03818529 is a clinical trial that has completed, run by American Thrombosis and Hemostasis Network. The registered enrollment target is 237 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818529 has completed, sponsored by American Thrombosis and Hemostasis Network.
- COMPLETED
- Registry status
- 237 participants
- Enrollment target
Study Summary
This is a multi-center cohort study of approximately 250 previously untreated patients (PUPs) with congenital moderate to severe hemophilia A or B in a network of up to 50 US Hemophilia Treatment Centers (HTCs). Participants will be followed as they receive their first 50 exposure days (ED) to clotting factor replacement product, both prospectively and retrospectively. The data collected on evolving treatment practices will define the incidence and risk factors for inhibitor development during the high risk period of first 50 ED and improve the outcomes of this vulnerable population.
Primary Outcome
Participants will be followed to assess inhibitor development (per CDC laboratory criteria; \>0.5 Nijmegen Bethesda Units for hemophilia A and \>0.3 Nijmegen Bethesda Units for hemophilia B) within 50 exposure days. Blood specimens will be submitted to the CDC for inhibitor testing at various time points outlined in the protocol.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2022-12-31 |
What the finished NCT03818529 record still lists
NCT03818529 is an observational study that tracks outcomes without assigning an intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03818529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03818529 about?
NCT03818529 is a clinical study titled "ATHN 8: Previously Untreated Patients (PUPs) Matter Study". This is a multi-center cohort study of approximately 250 previously untreated patients (PUPs) with congenital moderate to severe hemophilia A or B in a network of up to 50 US Hemophilia Treatment Centers (HTCs). Participants will be followed as they receive their first 50 exposure days (ED) to clott...
What is the current status of trial NCT03818529?
This trial is currently completed. The enrollment target is 237 participants. The study started on 2018-10-03. Estimated completion is 2022-12-31.
Who is sponsoring clinical trial NCT03818529?
This trial is sponsored by American Thrombosis and Hemostasis Network, which has 8 total clinical trials registered on ClinicalTrials.gov.
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