SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase IIa Randomized, Double-blind, Parallel Group, Placebo-controlled, multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Multiple Intravenous Injection of SY-005（recombinant human annexin A5） in Sepsis Subjects. 96 patients will be entered into the study and randomised in a 1:1:1:1 ratio to receive SY-005 2.5mg or SY-005 5mg or SY-005 10mg or placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Criteria

Key Inclusion Criteria:

• Patients are diagnosed with sepsis and receive study treatment within 48 hours

• Sepsis-related Organ Failure Assessment（SOFA）score range from 2 to 13

• The informed consent form signed by the patient or the patient's legally acceptable representative

Key Exclusion Criteria:

• Pregnant or breastfeeding women ; Women of childbearing potential (WOCBP) could not take effective method of contraception

• Moribund, and death is considered imminent within 24 hours or patient expected survival time is less than 6 months due to the underlying disease

• Absolute neutrophil count (ANC) <0.5 x 10^9/L

• New York Heart Association (NYHA) classification IV

• Patient with end-stage lung disease

• eGFR <60ml/min

• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3.0 times the upper limit of normal (ULN)

• Immunosuppressed patients with following situations:

1. Human immunodeficiency virus (HIV) infection

2. Patients undergoing active radiation or chemotherapy treatment within the past 3 months

3. Any organ or bone marrow transplant and related immunosuppressive therapy

4. High dose steroids (eg, > 0.5 mg/kg prednisone or a steroid with equivalent activity, daily for a month) within 3 months before provision of written informed consent for the study

• Patients with high bleeding risk:

1. Recent surgery <72 hours, or a planned surgical procedure in the next 24h

2. Severe thrombocytopenia (< 30 x 10^9/L, before platelet transfusion)

3. Recent trauma <72 hours

4. History of gastrointestinal bleeding or intracranial hemorrhage in the past 6 weeks.

5. Stroke or head injury in the past 3 months

6. On-going therapeutic anticoagulants that could not be interrupted (except prophylactic heparin treatment that can be continued）

7. Any history of Chronic liver disease with a Child score B or C

8. Any condition at risk of bleeding, as appreciated by the physician in charge of the patient

• Severe anemia (hemoglobin <5.9 g/dL)