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This is a multicenter, randomized, placebo-control, phase III study to investigate hetrombopag in subjects with severe AA who are treated naive.
180 treated naive patients with SAA will be enrolled in the study. The primary objective of the study will be the rate of complete hematologic response at six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hetrombopag Olamine+Standard Therapy | Experimental |
| |
| Placebo+Standard Therapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine+Standard Therapy | Drug | once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete hematologic response at six months. | 6 months |
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Inclusion Criteria:
1.15 Years to 75 Years (weight greater than 50 kg if Age < 18 years old). 2.Severe aplastic anemia characterized by Bone marrow cell proliferation less than 25 percent (If ≥25% but <50%, the remaining hematopoietic cells should be <30%) AND At least two of the following: Absolute neutrophil count <0.5×109/L; Platelet count <20×109/L; Absolute reticulocyte count <20×109/L.
3.Unsuitable or unwilling to perform hematopoietic stem cell transplantation (HSCT).
4.Signed informed consent.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300041 | China |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| Placebo+Standard Therapy |
| Drug |
once daily |
|
| D001855 | Bone Marrow Diseases |