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The Efficacy and Safety of Ta1 for Sepsis (TESTS)

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ClinicalTrials.gov Identifier: NCT02867267
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
SciClone Pharmaceuticals
Information provided by (Responsible Party):
Wu Jianfeng, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Sepsis Drug: Thymosin alpha 1 Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: thymosin alpha 1
1ml subcutaneous injection with 1.6 mg thymalfasin for 7 days, BID
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.
Other Name: thymalfasin

Placebo Comparator: Placebo
1ml subcutaneous injection with 1.6 mg placebo for 7 days , BID
Other: Placebo
Subcutaneous injections of 1.6 mg twice per day for seven days, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.




Primary Outcome Measures :
  1. 28-day all-cause mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Incidence of secondary infection (recurrence, double infection and new infection) from Day 0 to 28 [ Time Frame: 28 days ]
  2. 28-day clearance rate of pathogenic microorganism [ Time Frame: 28 days ]
  3. ICU stays [ Time Frame: 90 days ]
  4. Hospital stays [ Time Frame: 28 days ]
  5. 28-day re-hospitalization rate [ Time Frame: 28 days ]
  6. SOFA score (at days -1, 7, 14 and 28) [ Time Frame: 28 days ]
  7. 90-day all-cause mortality [ Time Frame: 90 days ]
  8. ICU mortality [ Time Frame: 90 days ]
  9. 28-day ventilator-free days [ Time Frame: 28 days ]
  10. 28-day ICU-free days [ Time Frame: 28 days ]
  11. 28-day CRRT-free days [ Time Frame: 28 days ]
  12. 28-day Vasoactive agents-free days [ Time Frame: 28 days ]
  13. Variance of the count of monocyte human lymphocyte antigens (mHLA) -DR at days 7, 14 and 28 compared with the baseline (day -1) [ Time Frame: 28 days ]
  14. The count of Treg cells at days -1 and 7 [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤85
  2. Signed informed consent signed
  3. Presence of at least one acute and severe organ failure related to sepsis and at least one SOFA>1
  4. Infected focus are confirmed or suspected and satisfy at least one of the followings:

    1. pathogenic microbes grow in blood and 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. Systemic autoimmune disease
  3. Under pregnancy or in suckling period
  4. Presence of hematologic malignancies
  5. The patient is inclined to stop or cancel the artificial intervention for sustaining life, in other words, has abandoned treatment
  6. The patient could die of an underlying disease within 28 days or is in end-stage
  7. The patient could die within 24 hours
  8. The patient has undergone CPR in the past 72 hours and the neuromechanism has not fully recovered
  9. The patient has in the past 30 days undergone certain clinical drug or instrument trials which could affect immunity (such as Xuebijing, ulinastatin and CRRT)
  10. The patient has a medical history of allergy or intolerance to thymalfasin
  11. The source of infection cannot be contained, for example: infections that cannot be hanlded during surgical operations and drainage
  12. The patient does not timely perform relevant test items in 24 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867267


Contacts
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Contact: Wu Jianfeng, M. D 020-87755766 ext 8454 wujianfeng9571@163.com
Contact: Pei Fei, M. M peif26@163.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Zhou Feihu, M. D       zhoufh301@126.com   
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Long Yun, M. D    010-69152303    Ly_icu@aliyun.com   
The 309th Hospital of Chinese People's Liberation Army Not yet recruiting
Beijing, Beijing, China, 100000
Contact: Ma Penglin, M. D    010-66775014    Mapenglin1@163.com   
China, Guangdong
The First People's Hospital of Foshan Recruiting
Foshan, Guangdong, China, 528000
Contact: Zhou Lixin, M. D    0757-83162516    Drzhoulixin@gmail.com   
Sun Yat-Sen Medical Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: He Zhijie, M. D    020-81332339    Hezhijie2004@126.com   
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Li Yimin, M. D    020-83062905    dryiminli@vip.163.com   
The Sixth Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Kou Qiuye, M. D    020-38254043    kouqiuye@126.com   
Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wu Jianfeng, M.D    020-87755766 ext 8454    wujiafeng9571@163.com   
Contact: Guan Xiangdong, M.D    020-87755766 ext 8456    carlg@163.com   
Principal Investigator: Guan Xiangdong, M.D         
Sub-Investigator: Wu Jianfeng, M.D         
China, Jiangsu
Nanjing General Hospital of Nanjing Military Commend Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Li Weiqin, M. D    025-80861658    liweiqindr@vip.163.com   
China, Shanghai
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Chen Erzhen, M. D    021-4370045 ext 665896    chenerzhen@hotmail.com   
Shanghai Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200000
Contact: Zhu Duming, M. D    021-64041990 ext 2724    duming_zhu@163.com   
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610000
Contact: Kang Yan, M. D    028-85422508    Kangyan_hx@163.com   
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Cui Wei, M. D    0571-87783632    iamcuiwei@aliyun.com   
Zhejiang Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Yan Jing, M. D    0571-87987373    zjicu@vip.163.com   
Zhejiang Provincial People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Sun Renhuang, M. D    0571-85893283    Jqin168@hotmail.com   
Sponsors and Collaborators
Sun Yat-sen University
SciClone Pharmaceuticals
Investigators
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Principal Investigator: Guan Xiangdong, M. D First Affiliated Hospital, Sun Yat-Sen University

Publications of Results:
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Responsible Party: Wu Jianfeng, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02867267     History of Changes
Other Study ID Numbers: ZDX-2015-11
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wu Jianfeng, Sun Yat-sen University:
thymosin alpha 1; thymalfasin; sepsis; immunodepression

Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Thymalfasin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs