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To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL0911 | Experimental |
| |
| QL0911 plus Placebo | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL0911 | Drug | QL0911 |
| |
| QL0911 plus Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of treatment responders. | Randomization up to 80 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration from the commencement of treatment to a platelet count ≥100×109/L | Randomization up to 30 days | |
| Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy | Randomization up to 150 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Ma | Contact | 0451-84883471 | majun0322@126.com | |
| Shukui Qin | Contact | 025-84453932 | qinsk81@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin First Hospital | Recruiting | Harbin | China |
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| Drug |
QL0911 plus Placebo |
|
| Placebo | Drug | Placebo |
|
| Number of adverse events (AEs)/serious adverse events (SAEs) | Randomization up to 150 days |
| Nanjing Tianyinshan Hospital | Recruiting | Nanjing | China |
|