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The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects received placebo for injection treatment will be administered subcutaneously once a week |
|
| Drug | Experimental | Subjects received Romiplostim for injection treatment will be administered subcutaneously once a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Romiplostim | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of weeks in which the platelet response counts increase above 50×10^9/L | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects whose platelet counts relative to the baseline increase ≥ 20×10^9/L | 6 weeks | |
| Proportion of subjects who have received emergency treatment to increase the platelet counts | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peking Union Medical College Hospital, | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37601010 | Derived | Zhou H, Zhou J, Wu D, Ma L, Du X, Niu T, Yang R, Liu J, Zhang F, Shi Q, Wang X, Jing H, Li J, Wang X, Cui Z, Zhou Z, Hou M, Shao Z, Jin J, Li W, Ren H, Hu J, Shen J, Liu L, Zeng Y, Zhou J, Liu X, Shen Y, Ding K, Taira T, Cai H, Zhao Y. Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China. Res Pract Thromb Haemost. 2023 May 23;7(5):100192. doi: 10.1016/j.rpth.2023.100192. eCollection 2023 Jul. |
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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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multi-center, Randomized, Placebo-controlled, Double-blinded then Open-label
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Placebo-controlled, Double-blinded then Open-label
|
| 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 |