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| Name | Class |
|---|---|
| UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG) | UNKNOWN |
| American Thrombosis and Hemostasis Network | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with severe congenital protein C deficiency | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein C Concentrate (Human) | Biological | Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Medical diagnoses associated with Ceprotin treatment | 2 to 5 years, or until the Registry is terminated | |
| Ceprotin treatment regimens | 2 to 5 years, or until the Registry is terminated | |
| Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs) | 2 to 5 years, or until the Registry is terminated |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment outcomes categorized by medical diagnosis | Evidence of halting or reversal of coagulopathy or thrombosis, end-organ damage, limb sparing, Length of Hospital Stay (LOS), and mortality | 2 to 5 years, or until the Registry is terminated |
| CEPROTIN use and treatment outcomes in pregnancy, labor and delivery, surgery and invasive procedures, different age groups, and, in the presence of pre-existing renal and/or hepatic dysfunction |
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Inclusion Criteria:
Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study:
Exclusion Criteria:
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Registry participants will be identified by working with Hemophilia Treatment Centers and Thrombosis Centers known to have participants with severe congenital Protein C deficiency, as well as by working with centers that use CEPROTIN in emergency care situations.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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|
| 2 to 5 years, or until the Registry is terminated |
| 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 |
| ID | Term |
|---|---|
| D020151 | Protein C Deficiency |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001796 | Blood Protein Disorders |
| D019851 | Thrombophilia |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D011486 | Protein C |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D019774 | Blood Coagulation Factor Inhibitors |
| D001685 | Biological Factors |
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