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This is a multicenter, placebo-control, phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia. All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.
Subjects will receive the same study drug (hetrombopag or placebo) as in study HR-TPO-SAA-III, with the same doses and administration schedule or with modifications based on the actual conditions.
The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug (hetrombopag or placebo) after the completion of the HR-TPO-SAA-III study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hetrombopag Olamine | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine | Drug | Hetrombopag Olamine; once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of subjects with clonal evolution at 6 months and 18 months | 6 months and 18 months | |
| All SIEs, regardless of whether they are related to the investigational product | 3 years | |
| All SAEs, regardless of whether they are related to the investigational product | 3 years | |
| All AEs resulting in discontinuation and withdrawal from study | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Red blood cell count | by 1day visit | |
| Hemoglobin | by 1day visit | |
| Platelet count |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | 300020 | China |
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| Placebo |
| Drug |
Placebo; once daily |
|
| by 1day visit |
| White blood cell count | by 1day visit |
| Neutrophil count | by 1day visit |
| Reticulocyte count | by 1day visit |
| The 6-month and 18-month survival rates of subjects | 6 months and 18 months |
| The recurrence rates at 6 months and 18 months | 6 months and 18 months |