A Phase 4 interventional study of thymosin alpha 1 and Placebo in Sepsis, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment
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
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 20 is below the median of 105 across 896 interventional studies indexed under Sepsis.
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Exclusion Criteria:
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.
Drug: thymosin alpha 1
Subcutaneous injections of placebo (saline) twice per day for seven days
Other: Placebo
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.
Also known as: thymalfasin
Subcutaneous injections of placebo (saline) twice per day for seven days
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
Time frame: 28days
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
Time frame: 28 days
Maximum observed serum concentration (Cmax) of Ta 1
Time frame: 7 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1
Time frame: 7 days
Terminal serum half-life (T-HALF) of Ta 1
Time frame: 7 days
Time of maximum observed serum concentration (Tmax) of Ta 1
Time frame: 7 days
Plan to share: Undecided
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University