Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants with severe congenital protein C deficiency who were treated under an emergency use IND. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein C Concentrate (Human) Vapor Heated | Drug | Protein C Concentrate (Human) Vapor Heated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Received a Dose of Protein C in Retrospective Study | Number of participants who received a dose of Protein C in retrospective study will be reported. | Throughout the study period (up to 6 months) |
| Number of Participants with Prophylactic Treatment Outcome | Participants experience any episodes of purpura fulminans (PF), coumarin induced skin necrosis (CISN), or thromboembolic event during prophylactic treatment will be assessed. | Throughout the study period (up to 6 months) |
| Number of Participants with Acute Episode Treatment Outcome | Acute episode treatment outcome includes type of episode (PF, CISN, Thromboembolic); Was treatment effective or not effective; Was patient successfully transitioned to anticoagulation following the resolution of the episode will be assessed. | Throughout the study period (up to 6 months) |
| Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment | An AE is defined as any untoward medical occurrence in a participant administered study product that does not necessarily have a casual relationship with the treatment. AEs considered possibly or probably related to Protein C Concentrate treatment will be recorded on case report forms (CRFs). | Throughout the study period (up to 6 months) |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children´s Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children´s Hospital Denver |
Not provided
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
| Denver |
| Colorado |
| 80218 |
| United States |
| Evans Army Hospital | Fort Carson | Colorado | 80973 | United States |
| Children´s Hospital Boston | Boston | Massachusetts | 02115 | United States |
| Rainbow Babies & Children´s Hospital | Cleveland | Ohio | 44106 | United States |
| The Children´s Medical Center - Dayton | Dayton | Ohio | 45404 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Cook Children´s Medical Center | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| Texas Children´s Hospital | Houston | Texas | 80218 | United States |
| 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided