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The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 mcg/kg AMG531 | Experimental | The administration of Romiplostim will be performed on Day 1 and 8 |
|
| 3 mcg/kg AMG531 | Experimental | The administration of Romiplostim will be performed on Day 1 and 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romiplostim | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of all adverse events including evaluation of antidrug antibody status | Up to 43 days after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chinese academy of medical science hematology hospital | Chinese academy of medical science hematology hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union hospital | Beijing | China | ||||
| West China hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34921514 | Derived | Qi J, Zheng L, Hu B, Zhou H, He Q, Liu H, Kawai H, Yang R. Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial. Clin Pharmacol Drug Dev. 2022 Mar;11(3):379-387. doi: 10.1002/cpdd.1059. Epub 2021 Dec 17. |
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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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| ID | Term |
|---|---|
| C488777 | romiplostim |
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| Chengdu |
| China |
| Chinese academy of medical science hematology hospital | Tianjin | China |
| Wuxi People's Hospital | Wuxi | China |
| Henan Cancer Hospital | Zhengzhou | China |
| 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 |