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Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea.
Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Study Participants | Participants with congenital hemophilia B (FIX level ≤5%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIXUBIS | Biological | Recombinant Factor IX (rFIX) for intravenous use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs) | Seriousness and severity of AEs, including any inhibitory antibody development and/or anaphylactic reactions | Throughout the study period of approximately 2 years and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physician rated effectiveness of RIXUBIS for prophylactic treatment in participants <12 years old | Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none | Up to 6 months from baseline while on treatment |
| Participant rated effectiveness of RIXUBIS for prophylactic treatment in participants ≥12 years old |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with hemophilia B in South Korea who have been prescribed RIXUBIS.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daegu Catholic University Medical Center | Daegu | 42472 | South Korea | |||
| DaeJeon Eulji University Hospital |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
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Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none |
| Up to 6 months from baseline while on treatment |
| Physician rated effectiveness of RIXUBIS for on-demand treatment in participants <12 years old | Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none | Up to 6 months from baseline while on treatment |
| Participant rated effectiveness of RIXUBIS for on-demand treatment in participants ≥12 years old | Rated on a 4-point ordinal scale: Excellent, Good, Moderate, or none | Up to 6 months from baseline while on treatment |
| Daejeon |
| 35233 |
| South Korea |
| Chung Hospital | Gyeonggi-do | 13316 | South Korea |
| Kim Hugh Chul Internal Medicine | Seoul | 05538 | South Korea |
| Korea Hemophilia Foundation | Seoul | 06641 | South Korea |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |