Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
NCT ID: NCT02883595
Last Updated: 2019-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2016-03-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
Placebo
Subcutaneous injections of placebo (saline) twice per day for seven days
Placebo
Subcutaneous injections of placebo (saline) twice per day for seven days
Interventions
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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.
Placebo
Subcutaneous injections of placebo (saline) twice per day for seven days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 yrs
3. Presence of sepsis/ septic shock according to sepsis 3.0
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Wu Jianfeng
Clinical Professor
Principal Investigators
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Wu Jianfeng, M. D
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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thymosin alpha 1
Identifier Type: -
Identifier Source: org_study_id
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