Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

Sun Yat-sen University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sepsis

Interventions

thymosin alpha 1DRUG

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.

PlaceboOTHER

Subcutaneous injections of placebo (saline) twice per day for seven days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent from the patients or their next of kin for patients unable to consent 2. Age ≥18 yrs 3. Presence of sepsis/ septic shock according to sepsis 3.0 Exclusion Criteria: 1. Pregnant or lactation period. 2. Age \<18 yrs 3. Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month. 4. History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation; 5. Acute pancreatitis with no established source of infection. 6. Not expected to survive 28 days because of end-stage diseases. 7. Participation in another clinical trial.

Locations (1)

Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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