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This is a multicenter, randomized, double-blind, and open-label, placebo-controlled phase II clinical study. In order to evaluate the effectiveness and safety of trappa ethanolamine tablets combined with ciclosporin in the treatment of patients with non-severe aplastic anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trappa ethanolamine tablets combined with ciclosporin | Experimental |
| |
| Placebo combined with ciclosporin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trappa ethanolamine tablets ; ciclosporin | Drug | Trappa ethanolamine tablets combined with ciclosporin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Full hematological response rate | About 13 weeks from the first medication to the evaluation. |
| Measure | Description | Time Frame |
|---|---|---|
| Partial hematological response rate and total hematological response rate | About 13 weeks from the first medication to the evaluation | |
| Hematological response rate | About 26 weeks from the first medication to the evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanyi Zhai | Contact | 0518-82342973 | wanyi.zhai.wz5@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Hospital of Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 30000 | China |
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| Placebo ; ciclosporin | Drug | Placebo combined with ciclosporin |
|
| The time required for the first hematological response | About 26 weeks from the first medication to the evaluation |
| Changes in platelet count relative to the baseline of each visiting point of view | About 26 weeks from the first medication to the evaluation |
| Changes in hemoglobin relative to the baseline of each visiting point of view | About 26 weeks from the first medication to the evaluation |
| Changes in absolute neutrophil count relative to the baseline of each visiting point of view | About 26 weeks from the first medication to the evaluation |
| Changes in reticulocyte count relative to the baseline of each visiting point of view | About 26 weeks from the first medication to the evaluation |
| Cumulative proportion of patients who need blood transfusion | About 26 weeks from the first medication to the evaluation |
| Cumulative total amount of platelet transfusions | About 26 weeks from the first medication to the evaluation |
| Cumulative amount of red blood cell infusions | About 26 weeks from the first medication to the evaluation |
| Cumulative proportion of patients with disease progression | About 26 weeks from the first medication to the evaluation |
| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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