The Efficacy and Safety of Ta1 for Sepsis

NCT02867267 | Completed Phase 3 DMC

• 1 other identifier: ZDX-2015-11
• Study Type: interventional
• Target: 1,106
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Sepsis

Keywords

thymosin alpha 1; thymalfasin; sepsis; immunodepression

Outcome Measures

Primary Outcomes (1)

• 28-day all-cause mortality

  28 days

Secondary Outcomes (15)

• Incidence of new onset infection within 28 days

  28 days

• 28-day clearance rate of pathogenic microorganism

  28 days

• ICU stays

  90 days

• Hospital stays

  28 days

• 28-day re-hospitalization rate

  28 days

Study Arms (2)

thymosin alpha 1

EXPERIMENTAL

1ml subcutaneous injection with 1.6 mg thymosin alpha 1, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition

Drug: Thymosin alpha 1

Placebo

PLACEBO COMPARATOR

1ml subcutaneous injection with placebo, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition

Other: Placebo

Interventions

Thymosin alpha 1 DRUG

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.

Also known as: thymalfasin

thymosin alpha 1

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤85;
• Signed informed consent signed;
• 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;
• Infected focus are confirmed or suspected and satisfy at least one of the followings:
• pathogenic microbes grow in blood or at aseptic locations
• presence of abscess or partially-infected tissues
• 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)

You may not qualify if:

• History of organ or bone marrow transplantation;
• Acute phase connective tissue diseases (such as rheumatoid diseases, systemic lupus erythematosus) and glomerulonephritis;
• Under pregnancy or in suckling period;
• Presence of hematologic malignancies;
• The patient has received radiotherapy or chemotherapy within the past 30 days;
• The patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment;
• 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);
• The patient could die of an underlying disease within 28 days or is in end-stage;
• The patient has undergone CPR in the 72 hours before signing the informed consent and the neuromechanism has not fully recovered (GCS score ≤ 8);
• 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);
• The patient has a medical history of allergy or intolerance to thymalfasin;
• The source of infection cannot be contained, for example: infections that cannot be handled during surgical operations and drainage.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• SciClone Pharmaceuticals: collaborator

Study Sites (22)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

Location

The First People's Hospital of Foshan

Foshan, Guangdong, 528000, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510000, China

Location

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

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

The Sixth Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Location

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

Wuhan, Hubei, China

Location

Nanjing General Hospital of Nanjing Military Commend

Nanjing, Jiangsu, 210000, China

Location

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250014, China

Location

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, 310000, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Related Publications (5)

• Wu 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: 23327199 RESULT

• Romani 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: 17495242 RESULT

• Romani 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: 23045964 RESULT

• Wang 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: 20549321 RESULT

• Wu 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.

  PMID: 39814420 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Guan Xiangdong, M. D

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 15, 2016
• Study Start: September 6, 2016
• Primary Completion: January 22, 2021
• Study Completion: March 23, 2021
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (22)