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The main purpose of this extended study is to enable subjects who are currently receiving the PartB experimental drug in the HR-TPO-ITP-III-PED clinical trial .To continue receiving the experimental drug after the completion of the clinical trial if they benefit from the treatment at the end of the clinical trial.Until the study physician determines that the subject has failed treatment or that the subject can no longer benefit from treatment or extends the study treatment for 6 months.In addition, the secondary purpose of this extended study was to observe the long-term efficacy and safety of tripodal in children and adolescents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label | Experimental | Herombopag plus standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herombopag | Drug | Thrombopoietin receptor agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with new myelofibrosis,new cataract, or existing cataract progression during the extended study. | from baseline to 28 days after the last dose | |
| All AESIs,whether or not associated with study drugs. | from baseline to 28 days after the last dose | |
| All SAEs,whether or not associated with study drugs. | from baseline to 28 days after the last dose | |
| All AEs that result in discontinuation of medication. | from baseline to 28 days after the last dose | |
| All AEs that lead to permanent withdrawal. | from baseline to 28 days after the last dose | |
| Blood Biochemistry-ALT. | 6 months | |
| Blood Biochemistry-AST. | 6 months | |
| Blood Biochemistry-GGT. | 6 months | |
| Blood Biochemistry-ALP. | 6 months | |
| Blood Biochemistry-TBIL. | 6 months | |
| Blood Biochemistry-DBIL. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet count at each visiting point. | 6 months | |
| The incidence and severity of bleeding symptoms. | According to the 2021 version go pediatric ITP bleeding Score Scale. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyi Zhu, M.M | Contact | +0518-82342973 | zhenyi.zhu@hengrui.com |
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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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open-label Herombopag plus standard of care
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| 6 months |
| Blood Biochemistry-creatinine. | 6 months |
| Percentage of subjects receiving emergency treatment for aggravated ITP. | 6 months |
| Percentage of subjects with recurrent ITP. | 6 months |
| 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 |