Back to resultsThe Efficacy and Safety of Ta1 for Sepsis (TESTS)
Primary Purpose
Sepsis
Status
Completed
Phase
Phase 3
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; thymalfasin; sepsis; immunodepression
Eligibility Criteria
Inclusion Criteria:
- 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 failure 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 and 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)
Exclusion Criteria:
- History of organ or bone marrow transplantation;
- Active 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.
Sites / Locations
- Chinese PLA General Hospital
- Peking Union Medical College Hospital
- The First People's Hospital of Foshan
- Guangzhou First People's Hospital
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
- The First Affiliated Hospital of Guangzhou Medical University
- The Sixth Affiliated Hospital of Sun Yat-Sen University
- The First Affiliated Hospital, Sun Yat-sen University
- Qingyuan People's Hospital
- Peking University Shenzhen Hospital
- Zhuhai People's Hospital
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
- Nanjing General Hospital of Nanjing Military Commend
- The First Affiliated Hospital of Xi 'an Jiaotong University
- Shandong Provincial Hospital
- Shanghai Ruijin Hospital
- Shanghai Zhongshan Hospital, Fudan University
- West China Hospital, Sichuan University
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Zhejiang Hospital
- Zhejiang Provincial People's Hospital
- Beijing Friendship Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
thymosin alpha 1
Placebo
Arm Description
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
1ml subcutaneous injection with placebo, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition
Outcomes
Primary Outcome Measures
28-day all-cause mortality
Secondary Outcome Measures
Incidence of new onset infection within 28 days
from initial injection on day 0 to day 28
28-day clearance rate of pathogenic microorganism
ICU stays
Hospital stays
28-day re-hospitalization rate
Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28
90-day all-cause mortality
ICU mortality
Ventilator-free days within 28 days
ICU-free days within 28 days
CRRT-free days within 28 days
Vasoactive agents-free days within 28 days
90-day SF-36 QOL scale
Variance of the count of monocyte human lymphocyte antigens-DR (mHLA-DR) at days 7, 14 and 28 compared with the baseline at screening
The percentage of Treg cells at screening and days 7
Full Information
NCT ID
NCT02867267
First Posted
August 10, 2016
Last Updated
April 6, 2023
Sponsor
Sun Yat-sen University
Collaborators
SciClone Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02867267
Brief Title
The Efficacy and Safety of Ta1 for Sepsis
Acronym
TESTS
Official Title
The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 6, 2016 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
March 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
SciClone Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
thymosin alpha 1; thymalfasin; sepsis; immunodepression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
thymosin alpha 1
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1ml subcutaneous injection with placebo, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition
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 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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
28-day all-cause mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of new onset infection within 28 days
Description
from initial injection on day 0 to day 28
Time Frame
28 days
Title
28-day clearance rate of pathogenic microorganism
Time Frame
28 days
Title
ICU stays
Time Frame
90 days
Title
Hospital stays
Time Frame
28 days
Title
28-day re-hospitalization rate
Time Frame
28 days
Title
Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28
Time Frame
28 days
Title
90-day all-cause mortality
Time Frame
90 days
Title
ICU mortality
Time Frame
90 days
Title
Ventilator-free days within 28 days
Time Frame
28 days
Title
ICU-free days within 28 days
Time Frame
28 days
Title
CRRT-free days within 28 days
Time Frame
28 days
Title
Vasoactive agents-free days within 28 days
Time Frame
28 days
Title
90-day SF-36 QOL scale
Time Frame
90 days
Title
Variance of the count of monocyte human lymphocyte antigens-DR (mHLA-DR) at days 7, 14 and 28 compared with the baseline at screening
Time Frame
28 days
Title
The percentage of Treg cells at screening and days 7
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guan Xiangdong, M. D
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Facility Name
The First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The Sixth Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Qingyuan People's Hospital
City
Qingyuan
State/Province
Guangdong
Country
China
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Nanjing General Hospital of Nanjing Military Commend
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Zhejiang Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23327199
Citation
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.
Results Reference
result
PubMed Identifier
17495242
Citation
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.
Results Reference
result
PubMed Identifier
23045964
Citation
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.
Results Reference
result
PubMed Identifier
20549321
Citation
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. Erratum In: Inflammation. 2011 Jun;34(3):222-3.
Results Reference
result
Learn more about this trial
The Efficacy and Safety of Ta1 for Sepsis
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