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Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II phase, multi-center clinical research.
rhTPO
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhTPO | Experimental | rhTPO injection |
|
| control | Placebo Comparator | without rhTPO injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhTPO | Drug | rhTPO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to platelet transfusion independence in patients at 6 month | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Time to patients achieve a platelet count 30×10^9/L, 50×10^9/L or100×10^9/L | up to 1year | |
| Overall response rate up to 1 year after Immunosupressive therapy. | up to 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZONGHONG SHAO, MD. | Contact | 8613702036467 | shaozonghong@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zonghong Shao | Tianjin | Tianjin Municipality | 300052 | China |
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| ID | Term |
|---|---|
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
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| ID | Term |
|---|---|
| D013926 | Thrombopoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| placebo | Drug | without rhTPO |
|
|
| Megakaryocyte, granulocyte and erythrocyte recovery in bone marrow up to 1 year after IST. |
| up to 1 year |
| Time to red blood cell/platelet transfusion independence in patients up to 1 year after IST | up to 1 year |
| Percentage of patients achieve red blood cell/platelet transfusion independence at 3, 6, 9 and 12 months after IST. | up to 1 year |
| Intervals of red blood cell/platelet transfusion up to 1 year after IST. | up to 1 year |
| The reticulocyte count of patients up to 1 year after IST. | up to 1 year |
| Hospitalization days of patients. | up to 1 year |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | up to 1 year |
| Median hematopoietic response rate up to 1 year after IST. | up to 1 year |
| D001855 | Bone Marrow Diseases |
| 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 |