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NCT02546622 · ClinicalTrials.gov registry record
ATHN 2: Factor Switching Study
A clinical trial, sponsored by American Thrombosis and Hemostasis Network.
- Completed
- Registry status
- 310
- Enrollment target
NCT02546622 is a clinical trial that has completed, run by American Thrombosis and Hemostasis Network. The registered enrollment target is 310 participants.
The verdict
NCT02546622 has completed, sponsored by American Thrombosis and Hemostasis Network.
- COMPLETED
- Registry status
- 310 participants
- Enrollment target
Study Summary
This is a longitudinal, observational study of patients with Hemophilia A or B who are planning to switch to a newly approved coagulation factor replacement product, or who have recently switched factor products. The study will follow each patient for up to 1 year. Patients will be recruited at Hemophilia Treatment Centers (HTC) which are ATHN-affiliates. The primary outcome being studied is the development of inhibitor (i.e., antibodies to factor) at 1 year or 50 exposure days, whichever comes first. The study will be conducted at approximately 30 HTCs, with a planned enrollment of 600 patients.The entire study duration is projected to be approximately 6 years. In addition, optional substudies will be included for some products, as "Product-Specific Modules". These will be questionnaires to collect data for subjects receiving selected Factor products. For example, subjects receiving Kovaltry will be approached to participate in the 'Kovaltry Product-Specific Module'; subjects receiving Adynovate will be approached to participate in the 'Adynovate Product-Specific Module'. Questions will be related to product use, perceptions of product use, and other post-marketing consumer data.
Interventions
- BIOLOGICAL Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013
- BIOLOGICAL Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 310 participants |
| Start Date | 2015-09 |
| Est. Completion | 2020-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02546622
The ClinicalTrials.gov registry entry for NCT02546622 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 310 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 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013 is the first listed.
NCT02546622 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02546622 about?
NCT02546622 is a clinical study titled "ATHN 2: Factor Switching Study". This is a longitudinal, observational study of patients with Hemophilia A or B who are planning to switch to a newly approved coagulation factor replacement product, or who have recently switched factor products. The study will follow each patient for up to 1 year. Patients will be recruited at Hemo...
What is the current status of trial NCT02546622?
This trial is currently completed. The enrollment target is 310 participants. The study started on 2015-09. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT02546622?
The interventions under investigation include: Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013 (BIOLOGICAL), Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02546622?
This trial is sponsored by American Thrombosis and Hemostasis Network, which has 8 total clinical trials registered on ClinicalTrials.gov.
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