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This is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).
Evaluating the efficacy and safety of different human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP) This trial was designed as a multicenter, randomized, open, parallel controlled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group 1 | Experimental | rhTPO injection7500 U ;one time a day; 14 times of administration |
|
| experimental group 2 | Experimental | rhTPO injection15000 U;one time a day;14 times of administration |
|
| experimental group 3 | Experimental | rhTPO injection15000 U;1 time every other day, 7 times; |
|
| experimental group 4 | Experimental | rhTPO injection30000 U;1 time every other day, 7 times; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPO | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in Platelet count from baseline on day 14 after the first dose | for day 14 | |
| Total effective rate of ITP patients on day 14 (V6, D14 ± 1) after the first dose. | for day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in Platelet count from baseline on day 7 and day28 after the first dose | for day7and day28 | |
| the total effective rate of treatment in ITP patients on day 7 and day 28 | for day7and day28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China | ||
| Zhongshan Hospital Xiamen University |
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| AE | up to 28days |
| Incidence of anti-rhTPO antibodies | up to 28days |
| Cav | average Blood concentration at steady state Blood concentration at steady state Blood concentration at steady state | up to 28days |
| AUCss | up to 28days |
| Xiamen |
| Fujian |
| 361004 |
| China |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510260 | China |
| Guangdong Second People's Hospital | Guangzhou | Guangdong | 510317 | China |
| Guangzhou Panyu Central Hospital | Guangzhou | Guangdong | 511400 | China |
| Harbin Institute of Hematology and Oncology | Haerbin | Heilongjiang | 150010 | China |
| Henan University of Science and Technology First Affiliated Hospital | Luoyang | Henan | 471003 | China |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou | Henan | 450000 | China |
| Zhengzhou Central Hospital | Zhengzhou | Henan | 450007 | China |
| renmin Hospital of Wuhan University Hubei General Hospital | Wuhan | Hubei | 430060 | China |
| Loudi Central Hospital | Loudi | Hunan | 417118 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215000 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| First Affiliated Hospital Heilongjiang University of Chinese Medicine | Shenyang | Liaoning | 150040 | China |
| Xi An Central Hospital | Xi’an | Shanxi | 710499 | China |
| Chinese Academy of Medical Sciences Blood Disease Hospital | Tianjin | Tianjin Municipality | 300020 | China |
| Xinjiang Uygur Autonomous Region Chinese Medicine Hospital, | Ürümqi | Xinjiang | China |
| Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310006 | China |
| Lishui City Center Hospital | Lishui | Zhejiang | 323000 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Xinjiang | China |
| Xinxiang Central Hospital, | Xinxiang | 453699 | China |