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Clinical trialNCT02546622CompletedObservational

ATHN 2: Factor Switching Study

SponsorAmerican Thrombosis and Hemostasis NetworkEnrollment310Hemophilia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Ellis J Neufeld, MD, PhD

    St. Jude Children's Research Hospital

    Principal Investigator
  • Janna Journeycake, MD

    Oklahoma Center for Bleeding and Clotting Disorders

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

27 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of California San Diego (ucsd)

    San Diego, California, United States

  • University of Colorado Denver Hemophilia and Thrombosis Center

    Aurora, Colorado, United States

  • Yale Hemophilia Treatment Center

    New Haven, Connecticut, United States

  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

  • Johns Hopkins All Children'S Hospital

    St. Petersburg, Florida, United States

  • St. Joseph'S Children'S Hospital

    Tampa, Florida, United States

  • Children'S Healthcare of Atlanta/emory

    Atlanta, Georgia, United States

  • Bleeding and Clotting Disorders Institute

    Peoria, Illinois, United States

  • Indiana Hemophilia and Thrombosis Center (ihtc)

    Indianapolis, Indiana, United States

  • Louisiana Center for Bleeding and Clotting Disorders

    New Orleans, Louisiana, United States

  • Maine Hemophilia and Thrombosis Center

    Scarborough, Maine, United States

  • Johns Hopkins University Medical Center

    Baltimore, Maryland, United States

  • Boston Hemophilia Center at Children'S Hospital of Boston

    Boston, Massachusetts, United States

  • University of Michigan Hemophilia and Coagulation Disorders Program

    Ann Arbor, Michigan, United States

  • Michigan State University Center for Bleeding and Clotting Disorders

    East Lansing, Michigan, United States

  • Children'S Mercy Hospital

    Kansas City, Missouri, United States

  • Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center

    Lebanon, New Hampshire, United States

  • Weill Cornell Medicine

    New York, New York, United States

  • Mary M. Gooley Hemophilia Center

    Rochester, New York, United States

  • Oregon Health and Science University

    Portland, Oregon, United States

  • Children'S Hospital of Philadelphia (chop)

    Philadelphia, Pennsylvania, United States

  • Pennsylvania Comprehensive Hemophilia and Thrombophilia Program / Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States

  • the Hemophilia Center of Western Pennsylvania

    Pittsburgh, Pennsylvania, United States

  • St Jude Children'S Research Hospital

    Memphis, Tennessee, United States

  • Utsw Medical Center at Dallas/children'S Medical Center

    Dallas, Texas, United States

  • Washington Center for Bleeding Disorders Bloodworks Northwest D/b/a Puget Sound Blood Center

    Seattle, Washington, United States

  • Blood Center of Wisconsin

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2015
Primary completion
30 Jun 2020
Completion
30 Jun 2020
Last update posted
9 Dec 2021
Registered enrollment
310
Registry id
NCT02546622

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.