Sepsis Clinical Trial
Official title:
A 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 in Sepsis Subjects
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
China | Zhongda Hospital,Affiliated to Southeast University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Suzhou Yabao Pharmaceutical R&D Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability Parameters of SY-005 | Number of patients with treatment-emergent adverse events over 28 days | From Day 0 to Day 28 | |
Secondary | Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 1, Day3, Day5, Day7 | Baseline, Day 1, Day3, Day5, Day7 | ||
Secondary | Vasopressin Free Days From Day 0 to Day 28 | From Day 0 to Day 28 | ||
Secondary | Assessment of ICU-Free Days From Day 0 to Day 28 | From Day 0 to Day 28 | ||
Secondary | Ventilator-Free Days From Day 0 to Day 28 | From Day 0 to Day 28 | ||
Secondary | 7-Day and 28-Day Mortality | Over 7/28 Days Following First Dose | ||
Secondary | Change From Baseline in IL-1ß at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in IL-6 at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in Procalcitonin at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in Prothrombin Time at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in Thrombin Time at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in Activated Partial Thromboplastin Time at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in Fibrinogen at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in Chemokine(C-C motif) Ligand 2 at Day 3,Day5 | Baseline, Day 3,Day5 | ||
Secondary | Change From Baseline in Anti-drug Antibodies at Day7,Day14,Day28 | Baseline, Day7,Day14,Day28 |
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