Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by American Thrombosis and Hemostasis Network.
NCT02546622 is a clinical trial that has completed, run by American Thrombosis and Hemostasis Network. The registered enrollment target is 310 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Inhibitor development is the primary outcome. Subjects will be followed closely and tested at baseline, after 10 Exposure Days and 50 Exposure Days, and/or at 1 year. Specimens will be submitted to local laboratories and evaluated for inhibitor titers, and inhibitors will be confirmed by local laboratories and CDC.
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 |
What the finished NCT02546622 record still lists
NCT02546622 is an observational study that tracks outcomes without assigning an intervention. The registered 310 participants enrollment target is mid-sized for trials with a published cap.
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03039439 · 310 participants
Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors
- NCT04178018 · 310 participants · NA
Transvaginal Ultrasound and Photoacoustic Imaging of Ovary
- NCT04878094 · 310 participants · Phase 3
A Study of Intra-operative Imaging in Women With Ovarian Cancer
- NCT05459233 · 310 participants · NA
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia