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The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of Hetrombopag plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
The investigators anticipate to undertaking a parallel group, randomised controlled trial of 100 ITP patients. One part of the participants are randomly selected to receive hetrombopag with starting dose 5mg po qd for 8 weeks（increase daily dose to a maximum of 7.5 mg/day if platelet count<50000 per μL following at least 2 weeks of treatment) combining with dexamethasone (given at a dose of 40 mg qd for 4 consecutive days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of Hetrombopag combining with high-dose dexamethasone therapy for the treatment of newly diagnosed ITP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hetrombopag plus High-dose Dexamethasone | Experimental | Hetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days |
|
| High-dose Dexamethasone | Active Comparator | HD-DEX 40mg qd for 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hetrombopag 5mg po qd | Drug | hetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 26 week sustained overall response to ITP treatments | Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding. | 26-week after treatment started |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day initial complete response to ITP treatment | Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Shi | Contact | 8682169896 | shiyansjj@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengli Oilfield Central Hospital | Recruiting | Dongying | Shandong | China |
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| High-dose Dexamethasone | Drug | dexamethasone 40 mg qd for 4 days |
|
| 28 days after treatment started] |
| 28-day initial overall response to ITP treatment | Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding. | 28 days after treatment started |
| 8-week complete response to ITP treatment | Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding. Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding. No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding. | 8 weeks after treatment started |
| 8-week overall response to ITP treatment | No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding. | 8 weeks after treatment started |
| time to response | the time from treatment initiation to achieve a complete response or a partial response | an average of 6 months |
| duration of response | the time from achievement of a complete response or a partial response to the loss of response | through study completion, an average of one year |
| therapy associated adverse events | through study completion, an average of one year |
| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000614661 | hetrombopag |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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