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Severe immune thrombocytopenia (ITP) is a life-threatening acquired hemorrhagic disease with dramatically decreased platelet number and clinical bleeding symptoms. Some patients with severe ITP did not respond to first-line treatment including steroids and IVIG. It was critical for them to use effective treatments to promote platelet and reduce the risk of fatal bleeding. In this study, the patients with severe ITP will be treated with hetrombopag, rhTPO, and the combination of hetrombopag and rhTPO, respectively. The effect evaluation includes the increase of platelet number and decrease of bleeding scores. Changes of coagulation, platelet activation, fribrinolysis influence, and thrombotic events will also be accessed for the safety of treatments. The aim of this study is to demonstrate that the combination of hetrombopag and rhTPO for severe ITP is more effective than the other two monotherapy and does not increase thrombotic events or thrombosis risk.
Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group. The effective rate of treatment, the rate and amplitude of platelet increase, the response time of platelet maintenance, and the effect of combination therapy on hemostasis will be compared. At the same time, the investigators will analyze the markers of thrombosis and thrombotic events to assess the safety of combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhTPO | Experimental | rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days. |
|
| Herombopag | Experimental | Herombopag will be taken orally at 5 mg daily for 28 days. |
|
| Herombopag in combination of rhTPO | Experimental | Herombopag will be taken orally at 5 mg daily for 28 days,while rhTPO will be injected subcutaneously at 300 u/kg daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTPO | Drug | subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | platelets ≥30*10E9/L, and at least 2 times higher than the baseline platelet count, and there is no hemorrhagic manifestations | From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment |
| The rate and magnitude of the increase in platelet count | The rate and magnitude of the increase in platelet count after treatment | From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment |
| Platelet maintenance response time | Platelets stay above 30*10E9/L | From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet fuction | Platelet aggregation function assay and the expression of P selectin on platelet surface | From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment |
| the markers of thrombosis and fibrinolysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Tian | Contact | 15850150032 | tianhong0718@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Yin | First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jie Yin | Recruiting | Suzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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Patients with severe ITP will be randomly assigned to three groups: rhTPO group, Herombopag Group, Herombopag combined with rhTPO group.
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| Herombopag |
| Drug |
Orally by mouth |
|
platelet-derived microparticals in plasma, concentration of Plasminogen Activator Inhibitor-1 (PAI-1), D-D dimer, tissue plasminogen activator (tPA),urokinase-type plasminogen activator (uPA) and Thrombin activatable fibrinolysis inhibitor (TAFI)
| From randomization to 28 days after rhTPO/Herombopag/Herombopag+rhTPO treatment |
| Thrombotic events | the number/time/site of thrombotic events (lower extremity deep vein thrombosis, pulmonary embolism, intracranial thrombosis, .etc)in participants | From randomization to 3 months after rhTPO/Herombopag/Herombopag+rhTPO 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 |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |