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Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A:Hetrombopag | Experimental |
| |
| Group B:Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag | Drug | Hetrombopag |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of treatment responders. | Randomization up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L | Randomization up to 30 days | |
| Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification | Randomization up to 150 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Najing Bayi Hospital | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38882443 | Derived | Qin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024. |
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| ID | Term |
|---|---|
| C000614661 | hetrombopag |
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Hetrombopag compared with placebo
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| Drug |
Placebo |
|
| Proportion of subjects without serious bleeding event | Randomization up to 180 days |
| Number of subjects with any Adverse Event (AE) or Serious Adverse Event (SAE) graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 5.0 | Randomization up to 180 days |