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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031250712 | Registry Identifier | jRCT |
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This study is conducted in Japan of vonicog alfa (rVWF) used to treat pediatric participants with Von Willebrand Disease (vWD).
The main aim of the study is to evaluate adverse drug reaction and effectiveness of vonicog alfa (rVWF).
During the study, pediatric participants with vWD will be administered with rVWF under routine normal practice. The investigators will evaluate adverse events due to rVWF for 1 year from the start of drug administration.
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 |
|---|---|---|---|
| vonicog alfa (rVWF) Group | Participants with Von Willebrand Disease (vWD) who received vonicog alfa (rVWF) in accordance with package insert. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vonicog alfa (rVWF) | Drug | rVWF administered by intravenous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience at Least One Adverse Drug Reactions (ADRs) | Adverse Event (AE) refers to any undesirable medical occurrence in a patient administered a drug, regardless of causal relationship. This includes any unfavorable or unintended sign (including abnormal laboratory findings), symptom, or disease occurring during administration, regardless of causal relationship. Adverse drug reaction (ADR) refers to AE related to administered drug. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic Efficacy Assessed by Hemostatic Efficacy Rating Scale | Hemostatic efficacy for bleeding episodes will be assessed by a predefined 4-point rating scale (Excellent, Good, Moderate, None). | 1 year |
| Hemostatic Efficacy during Perioperative Periods Assessed by Hemostatic Efficacy Rating Scale |
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Inclusion Criteria :
Exclusion Criteria :
- Patients who are participating in clinical trials of rVWF.
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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 |
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| Label | URL |
|---|---|
| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
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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 |
|---|---|
| D014842 | von Willebrand Diseases |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Hemostatic efficacy during perioperative periods will be assessed by a predefined 4-point rating scale (Excellent, Good, Moderate, None). |
| 1 year |
| Number of Infusions per Bleeding Episode | 1 year |
| Number of Infusions during Perioperative Periods | 1 year |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |