ATHN 2: Factor Switching Study
Public ClinicalTrials.gov record NCT02546622. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Longitudinal, Observational Study of Previously Treated Hemophilia Patients Switching Factor Replacement Products
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02546622
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 310 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2015 (Type not available)
- Primary completion
- Jun 30, 2020 (Actual)
- Completion
- Jun 30, 2020 (Actual)
- Last update posted
- Dec 9, 2021
2015 – 2020
United States locations
- U.S. sites
- 27
- U.S. states
- 22
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego (UCSD) | San Diego | California | 92122 | — |
| University of Colorado Denver Hemophilia and Thrombosis Center | Aurora | Colorado | 80045 | — |
| Yale Hemophilia Treatment Center | New Haven | Connecticut | 06520 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| St. Joseph's Children's Hospital | Tampa | Florida | 33607 | — |
| Children's Healthcare of Atlanta/Emory | Atlanta | Georgia | 30322 | — |
| Bleeding and Clotting Disorders Institute | Peoria | Illinois | 61615 | — |
| Indiana Hemophilia and Thrombosis Center (IHTC) | Indianapolis | Indiana | 46260 | — |
| Louisiana Center for Bleeding and Clotting Disorders | New Orleans | Louisiana | 70112 | — |
| Maine Hemophilia and Thrombosis Center | Scarborough | Maine | 04074 | — |
| Johns Hopkins University Medical Center | Baltimore | Maryland | 21205 | — |
| Boston Hemophilia Center at Children's Hospital of Boston | Boston | Massachusetts | 02115 | — |
| University of Michigan Hemophilia and Coagulation Disorders Program | Ann Arbor | Michigan | 48109 | — |
| Michigan State University Center for Bleeding and Clotting Disorders | East Lansing | Michigan | 48823 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center | Lebanon | New Hampshire | 03756 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| Mary M. Gooley Hemophilia Center | Rochester | New York | 14621 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | — |
| Pennsylvania Comprehensive Hemophilia and Thrombophilia Program / Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| The Hemophilia Center of Western Pennsylvania | Pittsburgh | Pennsylvania | 15213 | — |
| St Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| UTSW Medical Center at Dallas/Children's Medical Center | Dallas | Texas | 75235 | — |
| Washington Center for Bleeding Disorders Bloodworks Northwest d/b/a Puget Sound Blood Center | Seattle | Washington | 98104 | — |
| Blood Center of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02546622, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 9, 2021 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02546622 live on ClinicalTrials.gov.