Back to resultsEfficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
Primary Purpose
Sepsis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
thymosin alpha 1
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis focused on measuring thymosin alpha 1; sepsis; monocyte; pharmacokinetics
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
thymosin alpha 1
Placebo
Arm 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.
Subcutaneous injections of placebo (saline) twice per day for seven days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Maximum observed serum concentration (Cmax) of Ta 1
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1
Terminal serum half-life (T-HALF) of Ta 1
Time of maximum observed serum concentration (Tmax) of Ta 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02883595
Brief Title
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
Official Title
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2016 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
thymosin alpha 1; sepsis; monocyte; pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
thymosin alpha 1
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subcutaneous injections of placebo (saline) twice per day for seven days
Intervention Type
Drug
Intervention Name(s)
thymosin alpha 1
Other Intervention Name(s)
thymalfasin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous injections of placebo (saline) twice per day for seven days
Primary Outcome Measure Information:
Title
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,
Description
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 Outcome Measure Information:
Title
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
Description
Concentration of Ta 1 was measured on day 0, 3 and 7 after injection drug or placebo
Time Frame
28 days
Title
Maximum observed serum concentration (Cmax) of Ta 1
Time Frame
7 days
Title
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
Title
Terminal serum half-life (T-HALF) of Ta 1
Time Frame
7 days
Title
Time of maximum observed serum concentration (Tmax) of Ta 1
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Jianfeng, M. D
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
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