Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

Sun Yat-sen University

Status and phase: Completed; Phase 4

Conditions: Sepsis

Treatments: Drug: thymosin alpha 1; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02883595

thymosin alpha 1

Details and patient eligibility

About

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

Full 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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

thymosin alpha 1

Experimental group

Description:

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.

Treatment:

Drug: thymosin alpha 1

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo