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The primary objectives of the trial are to assess the safety and pharmacokinetics profile of pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.
The study started from the lowest dose, 0.08mg/kg, each group will enroll 4 to 6 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.08mg/kg | Experimental | Pegol-sihematide injection, 0.08mg/kg, single-dose |
|
| 0.2mg/kg | Experimental | Pegol-sihematide injection, 0.2mg/kg, single-dose |
|
| 0.33mg/kg | Experimental | Pegol-sihematide injection, 0.33mg/kg, single-dose |
|
| 0.5mg/kg | Experimental | Pegol-sihematide injection, 0.5mg/kg, single-dose |
|
| 0.7mg/kg | Experimental | Pegol-sihematide injection, 0.7mg/kg, single-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegol-sihematide injection | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 28 days after injection | |
| Maximum Plasma Concentration [Cmax] | 10min before injection to 336h after injection | |
| Time to Maximum Plasma Concentration [Tmax] | 10min before injection to 336h after injection | |
| Half-life [t1/2] | 10min before injection to 336h after injection | |
| Area Under the Curve [AUC]). | 10min before injection to 336h after injection |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of hemoglobin (g/L) after treatment | From date of recruitment until the date of biggest documented progression up to 28 weeks | |
| The changes of reticulocyte (10^9/L) after treatment | From date of recruitment until the date of biggest documented progression up to 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhijian Xiao, Doctor | Contact | +86-022-23909184 | zjxiao@medmail.com.cn | |
| Fengkui Zhang, Doctor | Contact | +86-022-23909229 |
| Name | Affiliation | Role |
|---|---|---|
| Zhijian Xiao, Doctor | Hospital of Blood Diseases, Chinese Academy of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Blood Diseases, Chinese Academy of Medical Sciences | Recruiting | Tianjin | 300020 | China |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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