The Efficacy and Safety of Ta1 for Sepsis

• Status: Completed
• Trial end date: 2021-03-23
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: SciClone Pharmaceuticals
• Treatments: Thymalfasin

Criteria

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 failure 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 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. Active 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.