Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

Sepsis Clinical Trial

Official title:

Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883595
• Other study ID #: thymosin alpha 1
• Status: Completed
• Phase: Phase 4
• Start date: March 31, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• thymosin alpha 1
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.

Other:
• Placebo
Subcutaneous injections of placebo (saline) twice per day for seven days

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Maximum observed serum concentration (Cmax) of Ta 1		7 days
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1		7 days
Secondary	Terminal serum half-life (T-HALF) of Ta 1		7 days
Secondary	Time of maximum observed serum concentration (Tmax) of Ta 1		7 days