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To evaluate the efficacy and safety of QL0911 in Chemotherapy- Induced Thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL0911 Group 1 | Experimental | Starting dose 1μg/kg;PLT 100~200×10^9/L |
|
| QL0911 Group 2 | Experimental | Starting dose 2μg/kg;PLT 100~200×10^9/L |
|
| QL0911 Group 3 | Experimental | Starting dose 2μg/kg;PLT <100×10^9/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL0911 | Drug | Qilu investigational product (QL0911 or placebo) will be administered in the clinic by a qualified healthcare provider as a subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effective response rate of QL0911 on the 21st day (21-days chemotherapy cycle) after administration. | 21 days | |
| The effective response rate of QL0911 on the 28th day (28-days chemotherapy cycle) after administration. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of platelet count from baseline in each visit(21-days chemotherapy cycle) | 21 days | |
| Changes of platelet count from baseline in each visit(28-days chemotherapy cycle) | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
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