Current partner codePEPTIDESDE
NCT02867267·Phase 3·INTERVENTIONAL

The Efficacy and Safety of Ta1 for Sepsis

Status

Completed

Phase

Phase 3

Enrollment

1,106

Locations

22

Results

Not posted

Publications

6

Study summary

What the protocol is testing.

The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis

Full detailed description

Our previous study reported that the 7-day treatment of Ta 1 demonstrated positive active effect as to the 28-day all-cause mortality and the augmentation of mHLA-DR (monocyte Human Leukocyte Antigen DR) at the secondary endpoint. Therefore, we intend to verify this finding through a randomized, double-blind and placebo-controlled clinical trial and the trail will include subjects with impaired immunologic functions.

Interventions

Treatment arms and agents.

DRUG

Thymosin alpha 1

Subcutaneous injections of 1.6 mg thymosin alpha 1 every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.

OTHER

Placebo

Subcutaneous injections of placebo every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.

Timeline

From registration to results.

  1. First posted

    Aug 15, 2016

  2. Study start

    Sep 6, 2016

  3. Primary completion

    Jan 22, 2021

  4. Study completion

    Mar 23, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Apr 10, 2023

Outcomes

What the study measures.

Primary outcomes

28-day all-cause mortality

Time frame · 28 days

Secondary outcomes

Incidence of new onset infection within 28 days

Time frame · 28 days

from initial injection on day 0 to day 28

28-day clearance rate of pathogenic microorganism

Time frame · 28 days

ICU stays

Time frame · 90 days

Hospital stays

Time frame · 28 days

28-day re-hospitalization rate

Time frame · 28 days

Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28

Time frame · 28 days

90-day all-cause mortality

Time frame · 90 days

ICU mortality

Time frame · 90 days

Ventilator-free days within 28 days

Time frame · 28 days

ICU-free days within 28 days

Time frame · 28 days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: 1. Age ≥ 18 and ≤85; 2. Signed informed consent signed; 3. Diagnosed as a sepsis according to the sepsis diagnosis criteria in "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016": at least one acute severe organ dysfunction related to sepsis, and total SOFA scores ≥2; 4. Infected focus are confirmed or suspected and satisfy at least one of the followings: 1. pathogenic microbes grow in blood or at aseptic locations 2. presence of abscess or partially-infected tissues 3. suspected infection identified by at least one of the following evidences: * leukocytes at normal aseptic locations * organic perforation (confirmed by imaging evidence, examination result or intestinal content leak during drainage) * Imaging evidence of pneumonia accompanied by purulent secretion * Related syndromes with high infection risk (cholangitis for example) Exclusion Criteria: 1. History of organ or bone marrow transplantation; 2. Acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis; 3. Under pregnancy or in suckling period; 4. Presence of hematologic malignancies; 5. The patient has received radiotherapy or chemotherapy within the past 30 days; 6. The patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment; 7. The patient has in the past 30 days received immunosuppressive drugs (tripterygium wilfordii, CellCept, cyclophosphamide, FK506, etc.) or received continuous treatment with prednisolone \>10 mg/day (or the same dose of other hormones); 8. The patient could die of an underlying disease within 28 days or is in end-stage; 9. The patient has undergone CPR in the 72 hours before signing the informed consent and the neuromechanism has not fully recovered (GCS score ≤ 8); 10. The patient has in the past 30 days used thymosin or undergone certain clinical drug or instrument trials which could affect immunity (such as Xuebijing, ulinastatin and CRRT); 11. The patient has a medical history of allergy or intolerance to thymalfasin; 12. The source of infection cannot be contained, for example: infections that cannot be handled during surgical operations and drainage.

Study locations

22 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Nanjing General Hospital of Nanjing Military Commend

Nanjing, Jiangsu, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Shandong Provincial Hospital

Jinan, Shandong, China

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, China

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Publications

Results and literature.

PMID 23327199Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.PMID 17495242Romani L, Bistoni F, Montagnoli C, Gaziano R, Bozza S, Bonifazi P, Zelante T, Moretti S, Rasi G, Garaci E, Puccetti P. Thymosin alpha1: an endogenous regulator of inflammation, immunity, and tolerance. Ann N Y Acad Sci. 2007 Sep;1112:326-38. doi: 10.1196/annals.1415.002. Epub 2007 May 10.PMID 23045964Romani L, Moretti S, Fallarino F, Bozza S, Ruggeri L, Casagrande A, Aversa F, Bistoni F, Velardi A, Garaci E. Jack of all trades: thymosin alpha1 and its pleiotropy. Ann N Y Acad Sci. 2012 Oct;1269:1-6. doi: 10.1111/j.1749-6632.2012.06716.x.PMID 20549321Wang X, Li W, Niu C, Pan L, Li N, Li J. Thymosin alpha 1 is associated with improved cellular immunity and reduced infection rate in severe acute pancreatitis patients in a double-blind randomized control study. Inflammation. 2011 Jun;34(3):198-202. doi: 10.1007/s10753-010-9224-1.PMID 42164588Pei F, Gu B, Liu Z, Li G, Nie Y, Chen M, Liu Y, Guan X, Chen Q, Wu J. Validation of SOFA-2 score in sepsis and exploration of its extension with additional immune markers. J Intensive Med. 2026 Jan 8;6(3):294-301. doi: 10.1016/j.jointm.2025.12.003. eCollection 2026 Jun.PMID 39814420Wu J, Pei F, Zhou L, Li W, Sun R, Li Y, Wang Z, He Z, Zhang X, Jin X, Long Y, Cui W, Wang C, Chen E, Zeng J, Yan J, Lin Q, Zhou F, Huang L, Shang Y, Duan M, Zheng W, Zhu D, Kou Q, Zhang S, Liu Y, Yao C, Shang M, Peng S, Zhou Q, Cheng KK, Guan X; TESTS study collaborator group. The efficacy and safety of thymosin alpha1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. BMJ. 2025 Jan 15;388:e082583. doi: 10.1136/bmj-2024-082583.

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