Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

Phase 4

Completed

• Conditions: Sepsis
• Interventions: Other: Placebo; Drug: thymosin alpha 1

• Registration Number: NCT02883595
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-03-31
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-30
• Primary Completion: 2016-09-30
• Study Completion: 2016-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subcutaneous injections of placebo (saline) twice per day for seven days
thymosin alpha 1	thymosin alpha 1	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.

Primary Outcome Measures

Name	Time	Method
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,	28days	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

Secondary Outcome Measures

Name	Time	Method
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	28 days	Concentration of Ta 1 was measured on day 0, 3 and 7 after injection drug or placebo
Maximum observed serum concentration (Cmax) of Ta 1	7 days
Terminal serum half-life (T-HALF) 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
Time of maximum observed serum concentration (Tmax) of Ta 1	7 days

Trial Locations

Locations (1)

Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China