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.
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
Status
Completed
Phase
Phase 4
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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 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
Interventions
Treatment arms and agents.
OTHER
Placebo
Subcutaneous injections of placebo (saline) twice per day for seven days
Timeline
From registration to results.
First posted
Aug 30, 2016
Study start
Mar 31, 2016
Primary completion
Sep 30, 2016
Study completion
Dec 31, 2016
Results posted
Not reported
Registry updated
Apr 4, 2019
Outcomes
What the study measures.
Primary outcomes
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
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
Maximum observed serum concentration (Cmax) of Ta 1
Time frame · 7 days
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
Terminal serum half-life (T-HALF) of Ta 1
Time frame · 7 days
Time of maximum observed serum concentration (Tmax) of Ta 1
Time frame · 7 days
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Sun Yat-sen University
Guangzhou, Guangdong, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Thymosin Alpha-1.
NCT IDStudyPhase / statusEnrollmentUpdated
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Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
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Not applicable
Completed
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2026-06
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
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Recruiting
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TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
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Not applicable
Active, not recruiting
50
2026-04
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
William B. Ershler, MD · COVID-19
Phase 2
Completed
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2026-04
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
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Phase 2
Recruiting
48
2026-03
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
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Recruiting
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Put the record in context.
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