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| Name | Class |
|---|---|
| Shenyang Sunshine Pharmaceutical Co., LTD. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .
The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10^9/L~100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment.
Platelet count, bleeding and other symptoms will be evaluated before and after treatment.
Platelet transfusion will be administered to subjects with active bleeding symptoms.
Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhTPO | Experimental | Active investigational product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTPO | Drug | Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10^9/L~100×10^9/L. |
| Measure | Description | Time Frame |
|---|---|---|
| The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L) | up to 16 weeks per subject |
| Measure | Description | Time Frame |
|---|---|---|
| The effective rate of maintenance treatments adopting different frequency of administration | up to 16 weeks per subject | |
| Number of subjects with Adverse Events as a Measure of Safety | up to 18 weeks per subject |
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Inclusion Criteria:
Exclusion Criteria:
Pregnancy or breast feeding.
Having a medical history of thrombosis.
Significant abnormal cardio-pulmonary function.
Abnormal liver and kidney function:
Synchronous tumor.
Cannot adopt adequate contraceptive precautions during the course of the study.
Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ).
Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongqiang Zhao, Dr. | Contact | 535114726@qq.com | ||
| Shujie Wang | Contact | yangwl2007@yahoo.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongqiang Zhao, Dr. | Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D057049 | Thrombotic Microangiopathies |
| 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 |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |