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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031240130 | Registry Identifier | jRCT |
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This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from recombinant ADAMTS13 and to check if recombinant ADAMTS13 improves or prevents cTTP.
During the study, participants with cTTP will take recombinant ADAMTS13 intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from recombinant ADAMTS13 for 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant ADAMTS13 | Participants will receive recombinant ADAMTS13 intravenous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant ADAMTS13 | Drug | Recombinant ADAMTS13, Intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE) | Up to 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Observed Platelet Count from Baseline at the End of Treatment | Percent change in platelet count from baseline at the end of treatment will be reported. | Up to 18 Months |
| Percent Change in Observed ADAMTS13 Activity from Baseline at the End of Treatment |
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Inclusion Criteria:
- All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13
Exclusion Criteria:
- None
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The population of this survey 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 | Japan |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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 |
|---|---|
| D011697 | Purpura, Thrombotic Thrombocytopenic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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Percent change in ADAMTS13 activity from baseline at the end of treatment will be reported. |
| Up to 18 Months |
| Percent Change in Observed ADAMTS13 Inhibitor from Baseline at the End of Treatment | Percent change in ADAMTS13 inhibitor from baseline at the end of treatment will be reported. | Up to 18 Months |
| Number of Participants with Thrombotic Thrombocytopenic Purpura (TTP) Events on Periodic Replacement Therapy | Number of participants with TTP events on periodic replacement therapy will be reported. | Up to 18 Months |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D019851 | Thrombophilia |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |