SepsisPhase 3TESTSNCT02867267
The Efficacy and Safety of Ta1 for Sepsis
A Phase 3 study testing Thymosin alpha 1 in people with Sepsis, run by Sun Yat-sen University at 22 sites in China.
Trial summary
The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Thymosin alpha 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,106 participants
- Where
- 22 sitesChina
- Study dates
- 6 Sep 2016to 23 Mar 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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;
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100000
Beijing Friendship Hospital, Capital Medical University
Beijing
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
The First People's Hospital of Foshan
Foshan, Guangdong, 528000
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510000
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
The Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Zhejiang Hospital
Hangzhou, Zhejiang, 310000
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Shandong Provincial Hospital
Jinan, Shandong, 250014
Nanjing General Hospital of Nanjing Military Commend
Nanjing, Jiangsu, 210000
Qingyuan People's Hospital
Qingyuan, Guangdong
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200000
Shanghai Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
Zhuhai People's Hospital
Zhuhai, Guangdong
About this study
Official title: The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial
The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis
Read the 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.
- Conditions
- Sepsis
- Being tested
- Thymosin alpha 1, Placebo
- Keywords
- thymosin alpha 1; thymalfasin; sepsis; immunodepression
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymosin alpha 1Drug
Also called thymalfasin
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all-cause mortality
Measured: 28 days
Secondary outcomes (15)
Incidence of new onset infection within 28 days
from initial injection on day 0 to day 28
Measured: 28 days
28-day clearance rate of pathogenic microorganism
Measured: 28 days
ICU stays
Measured: 90 days
Hospital stays
Measured: 28 days
28-day re-hospitalization rate
Measured: 28 days
Changes of SOFA score at screening, end of CTM, days 7 (if applicable), day 14 and day 28
Measured: 28 days
90-day all-cause mortality
Measured: 90 days
ICU mortality
Measured: 90 days
Ventilator-free days within 28 days
Measured: 28 days
ICU-free days within 28 days
Measured: 28 days
CRRT-free days within 28 days
Measured: 28 days
Vasoactive agents-free days within 28 days
Measured: 28 days
90-day SF-36 QOL scale
Measured: 90 days
Variance of the count of monocyte human lymphocyte antigens-DR (mHLA-DR) at days 7, 14 and 28 compared with the baseline at screening
Measured: 28 days
The percentage of Treg cells at screening and days 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start6 Sep 2016
- Primary completion22 Jan 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- SciClone Pharmaceuticals
- Responsible party
- Principal investigator, Wu Jianfeng, Sun Yat-sen University
- Investigators
- Guan Xiangdong, M. D, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867267
- Sponsor's protocol ID
- ZDX-2015-11
- Acronym
- TESTS
- Status last verified
- Apr 2023
- First submitted
- 10 Aug 2016
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23327199Romani 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.
PubMed 17495242Romani 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.
PubMed 23045964Wang 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.
PubMed 20549321Pei 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.
PubMed 42164588Wu 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.
PubMed 39814420
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02867267
- Acronym / sponsor ID
- TESTS / ZDX-2015-11
- Conditions
- Sepsis
- Keywords
- thymosin alpha 1; thymalfasin; sepsis; immunodepression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,106 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- SciClone Pharmaceuticals
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thymosin alpha 1 | Experimental | Drug: Thymosin alpha 11ml 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 |
| Placebo | Placebo comparator | Other: Placebo1ml subcutaneous injection with placebo, every 12±2 hours for not more than 7 days depending on the change of the subjects' condition |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymosin alpha 1Also: thymalfasinSubcutaneous 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. | Drug | thymosin alpha 1 |
| PlaceboSubcutaneous 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. | Other | Placebo |
Primary outcome
28-day all-cause mortality
Time frame: 28 days
15 secondary outcomes
Incidence of new onset infection within 28 days
Time frame: 28 days
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
CRRT-free days within 28 days
Time frame: 28 days
Vasoactive agents-free days within 28 days
Time frame: 28 days
90-day SF-36 QOL scale
Time frame: 90 days
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
The percentage of Treg cells at screening and days 7
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Results publication: PubMed 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.
- Results publication: PubMed 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.
- Results publication: PubMed 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.
- Results publication: PubMed 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.
- Derived from this study: PubMed 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.
- Derived from this study: PubMed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guan Xiangdong, M. D principal investigator
First Affiliated Hospital, Sun Yat-Sen University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thymosin alpha 1 in people with Sepsis, run by Sun Yat-sen University at 22 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day all-cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867267, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.