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This is a randomized, double blinded, placebo-controlled phase Ib clinical trial in adult patients with immune thrombocytopenia. Cross-over treatment will be allowed during the study.
Approximate 51 to 60 patients will be enrolled in dose escalation (3 cohorts, 8-20 subjects each with the ratio of 3:1 vs Placebo) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Active Comparator | Eligible subjects will be treated with planned dose of 100 mg, 200 mg and 300 mg HMPL-523 once daily for 8 weeks and 16 weeks open-label treatment. |
|
| placebo arm | Placebo Comparator | Eligible subjects will be treated with HMPL-523 matching placebo once daily for 8 weeks and 16 weeks open-label treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMPL-523 | Drug | HMPL-523 will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with any Adverse Event | Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | From first dose to within 28 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Maximum plasma concentration (Cmax) | Day 15, 16, 29, 43 and 47 |
| Area under the concentration-time curve in a selected time interval (AUC0-t) | Area under the concentration-time curve in a selected time interval (AUC0-t) |
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Inclusion Criteria:
Signed informed consent form
18~75 years old male of female
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Diagnosed immune thrombocytopenia before randomization with platelet decrease for more than 6 months.
Patients with refractory or relapsed ITP who have been treated with 1st line anti-ITP regimen or have experienced splenectomy.
Relative stable disease with World Health Organization (WHO) bleeding score of 0-1 and no rescue treatment needed within 2 weeks based on investigator's judgment.
Laboratory tests meet the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Hongyan Yin | Hutchison Medipharma Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood diseases hospital, Chinese academy of medical university | Tianjin | Tianjin Municipality | 300000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37028433 | Derived | Liu X, Zhou H, Hu Y, Yin J, Li J, Chen W, Huang R, Gong Y, Luo C, Mei H, Ding B, Gu C, Sun H, Leng Y, Ji D, Li Y, Yin H, Shi H, Chen K, Wang J, Fan S, Su W, Yang R. Sovleplenib (HMPL-523), a novel Syk inhibitor, for patients with primary immune thrombocytopenia in China: a randomised, double-blind, placebo-controlled, phase 1b/2 study. Lancet Haematol. 2023 Jun;10(6):e406-e418. doi: 10.1016/S2352-3026(23)00034-0. Epub 2023 Apr 4. |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| Placebo | Drug | HMPL-523 matching placebo will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment. |
|
| Day 15, 16, 29, 43 and 47 |
| Rate of Clinical Remission | Rate of Clinical Remission was defined as the proportion of patients with two consecutive visits in the first 8 weeks (including the 8th week) during the medication period, platelet count ≥30×10^9/L, and a 2-fold increase from baseline (no emergency treatment during the period) | Day 1 to 8 weeks treatment |
| 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 |