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Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of increasing platelet count in animal and human. This study is designed in dose escalation fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hetrombopag | Experimental | hetrombopag either at 2.5,5,10,20,30 or 40mg, p.o. once daily |
|
| placebo | Placebo Comparator | Subjects will be randomized (5:1 eltrombopag : placebo) to receive either eltrombopag or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine Tablets | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in platelet count above baseline(%)on Day1,3,5,8,10,12,15,17,19,22,25,28 after dosing | up to 4 weeks | |
| Composite pharmacokinetic (PK) parameters of eltrombopag following a single dose of eltrombopag | For 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | up to 4 weeks | |
| Change in vital signs | up to 4 weeks | |
| Change in clinical laboratory parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maozhi Liang, Dr | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
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| up to 4 weeks |