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The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Hetrombopag Olamine | Experimental |
| |
| Part B:Hetrombopag Olamine vs Hetrombopag Olamine Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hetrombopag Olamine | Drug | For Part A, all participants would receive hetrombopag treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months. | around 6 months. | |
| Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months | around 6 months | |
| Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months | around 6 months | |
| Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years | around 3 years | |
| Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years. | around 3 years. | |
| Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years; | around 3 years; |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment,around 3 years; | around 3 years; | |
| platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junye Xiong | Contact | 0518-82342973 | junye.xiong@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer and Blood Specialty Clinic | Not yet recruiting | Los Alamitos | California | 90254 | United States |
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| Hetrombopag Olamine ;Hetrombopag Olamine Placebo | Drug | For Part B,participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。 |
|
| around 3 years; |
| Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years; | around 3 years; |
| Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years. | around 3 years. |
| Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years. | around 3 years. |
| AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology | Not yet recruiting | Denver | Colorado | 80210 | United States |
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| Oncology & Hematology Associates of West Broward | Not yet recruiting | Coral Springs | Florida | 33065 | United States |
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| Mid-Florida Hematology & Oncology Centers, P.A. | Recruiting | Orange City | Florida | 32763 | United States |
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| Springfield Clinic | Not yet recruiting | Springfield | Illinois | 62702 | United States |
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| Morristown Medical Center | Not yet recruiting | Morristown | New Jersey | 07039 | United States |
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| New York Cancer and Blood Specialists One Oncology | Not yet recruiting | Shirley | New York | 11967 | United States |
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