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Sponsor decision to not proceed.
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This is an observational, retrospective study designed to assess outcomes in patients diagnosed with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) who were not treated with complement component (C5) inhibitor therapy. Data required to evaluate study outcomes will be abstracted from the medical records of all patients who meet study eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Diagnosed with HSCT-TMA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No study intervention will be administered as part of this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving TMA Response | TMA Response is defined as platelet count ≥ 50,000/mm^3, lactate dehydrogenase < 1.5 upper limit of normal, absence of schistocytes (if present at baseline), and increase in eGFR ≥ 30% from baseline or discontinuation of dialysis (for patients on dialysis at baseline) | During the 26-week period after HSCT-TMA diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving TMA response | During the 52-week period after HSCT-TMA diagnosis | |
| Changes in individual components of TMA response | Platelets, lactate dehydrogenase, eGFR, chronic kidney disease stage, dialysis status |
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Inclusion Criteria:
Exclusion Criteria:
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Adult and pediatric patients who were diagnosed with TMA within 6 months after a HSCT procedure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D057049 | Thrombotic Microangiopathies |
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| From baseline to 26 weeks and to 52 weeks after HSCT-TMA diagnosis |
| Overall survival | At 26 weeks and 52 weeks after HSCT-TMA diagnosis |
| Nonrelapse mortality | Death due to any cause during the study, with the exception of death due to underlying disease progression or relapse | At 26 weeks and 52 weeks after HSCT-TMA diagnosis |
| D000095542 | Cytopenia |