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Completed

NCT Number: NCT02883595

Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent from the patients or their next of kin for patients unable to consent
  • Age ≥18 yrs
  • Presence of sepsis/ septic shock according to sepsis 3.0

Exclusion criteria

  • Pregnant or lactation period.
  • Age <18 yrs
  • Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month.
  • History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation;
  • Acute pancreatitis with no established source of infection.
  • Not expected to survive 28 days because of end-stage diseases.
  • Participation in another clinical trial.

Treatment and study plan

Thymosin alpha 1

Drug

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 names: thymalfasin

Placebo

Other

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

Primary outcomes

  1. 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,

    Time frame: 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 outcomes

  1. 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

    Time frame: 28 days

    Concentration of Ta 1 was measured on day 0, 3 and 7 after injection drug or placebo

  2. Maximum observed serum concentration (Cmax) of Ta 1

    Time frame: 7 days

  3. 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

  4. Terminal serum half-life (T-HALF) of Ta 1

    Time frame: 7 days

  5. Time of maximum observed serum concentration (Tmax) of Ta 1

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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