| Registry | NCT01127529 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 43 (Actual) |
| Sponsor | Baxalta now part of Shire (Industry); collaborators: UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG), American Thrombosis and Hemostasis Network |
| Conditions | Protein C Deficiency |
| Interventions | Protein C Concentrate (Human) (Biological) |
| Dates | start 2010-06-23, primary completion 2015-06-22, completion 2015-06-22, first posted 2010-05-21, last updated 2021-03-17 |
| Locations | 28 sites in United States, Austria, Germany, Italy, Netherlands, United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Protein C Deficiency All trials of Protein C Concentrate (Human)
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Subjects with severe congenital protein C deficiency | Biological: Protein C Concentrate (Human) | Registry subjects will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have subjects with severe congenital protein C deficiency, as well as by working with centers that use Ceprotin in emergency care situations. |
Sex: All
Inclusion Criteria: Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study: * Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable * Males and females of any age, including neonates, children, adolescents and adults * Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment Exclusion Criteria: * None
| Facility | City | Country | Status |
|---|---|---|---|
| Phoenix, Arizona | United States | ||
| Orange, California | United States | ||
| Aurora, Colorado | United States | ||
| Indianapolis, Indiana | United States | ||
| Boston, Massachusetts | United States | ||
| Grand Rapids, Michigan | United States | ||
| Lebanon, New Hampshire | United States | ||
| Cincinnati, Ohio | United States | ||
| Columbus, Ohio | United States | ||
| Dayton, Ohio | United States | ||
| Fort Worth, Texas | United States | ||
| Houston, Texas | United States | ||
| Innsbruck | Austria | ||
| Vienna | Austria | ||
| Bonn | Germany | ||
| Frankfurt | Germany | ||
| Hanover | Germany | ||
| Heidelberg | Germany | ||
| Magdeburg | Germany | ||
| Magstadt | Germany | ||
| Milan | Italy | ||
| Palermo | Italy | ||
| Rome | Italy | ||
| Vicenza | Italy | ||
| Nijmegen | Netherlands | ||
| Bradford | United Kingdom | ||
| London | United Kingdom | ||
| Manchester | United Kingdom |