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The purpose of this study is to determine whether thymosin alpha 1 is effective on improving monocyte function and has the desired pharmacologic activity for sepsis
Part 1: To observe the function of thymosin alpha 1 in sepsis patients via improving phagocytosis, bacteria eradication and antigen-presenting on monocyte Part 2: Pharmacokinetics of thymosin alpha 1 for sepsis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thymosin alpha 1 | Experimental | Subcutaneous injections of 1.6 mg thymosin alpha 1 twice per day for seven days, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent. |
|
| Placebo | Placebo Comparator | Subcutaneous injections of placebo (saline) twice per day for seven days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thymosin alpha 1 | Drug | Subcutaneous injections of 1.6 mg thymosin alpha 1 twice per day for seven days, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent. |
| Measure | Description | Time Frame |
|---|---|---|
| Ta 1 improving immune function of monocyte for sepsis, used by flow cytometric to measure phagocytosis(CD11b, CD64), antigen presenting(HLA-DR, CD86 and PD-L1), and apoptosis(active caspase 3) on monocyte, | Phagocytosis was measured by expression of monocyte surface antigen CD64 and CD11b, as well as pHrodo™ BioParticles® Phagocytosis Kits to assessing phagocytic activity on monocyte; antigen presenting was measured by HLA-DR, costimulatory molecule CD86 and inhibitory molecule PD-L1 on monocyte; apoptosis was measured by active caspase 3 on monocyte | 28days |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between concentration of Ta 1 and prognosis of sepsis patients, measured by concentration of Ta 1, 28-day all-cause mortality, 28-day clearance rate of pathogenic microorganism, ICU stays and hospital stays | Concentration of Ta 1 was measured on day 0, 3 and 7 after injection drug or placebo | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wu Jianfeng, M. D | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077596 | Thymalfasin |
| ID | Term |
|---|---|
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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|
| Placebo | Other | Subcutaneous injections of placebo (saline) twice per day for seven days |
|
| Maximum observed serum concentration (Cmax) of Ta 1 |
| 7 days |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1 | 7 days |
| Terminal serum half-life (T-HALF) of Ta 1 | 7 days |
| Time of maximum observed serum concentration (Tmax) of Ta 1 | 7 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |