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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240322 | Registry Identifier | jRCT |
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This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency.
The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662).
During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freeze-dried Human Protein C Concentrate (TAK-662) | Participants will be administered Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freeze-dried Human Protein C Concentrate | Drug | Freeze-dried Human Protein C Concentrate (TAK-662) intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) | Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience at Least One TEAE of Venous Thromboembolism | Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum) | |
| Number of Participants who Experience at Least One TEAE of Purpura Fulminans |
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Inclusion Criteria:
- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662).
Exclusion Criteria:
- None
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The population of this study are all participants who meet the inclusion/exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda selected site | Recruiting | Tokyo | Tokyo | Japan |
De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites).
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| 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 |
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| Up to 12 months (For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, up to 24 months as a maximum) |
| D001796 | Blood Protein Disorders |
| D019851 | Thrombophilia |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |