Status:
UNKNOWN
SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
Lead Sponsor:
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Conditions:
Sepsis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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-0...
Eligibility Criteria
Inclusion
- Key
- 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
- 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:
- Human immunodeficiency virus (HIV) infection
- Patients undergoing active radiation or chemotherapy treatment within the past 3 months
- Any organ or bone marrow transplant and related immunosuppressive therapy
- 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:
- Recent surgery \<72 hours, or a planned surgical procedure in the next 24h
- Severe thrombocytopenia (\< 30 x 10\^9/L, before platelet transfusion)
- Recent trauma \<72 hours
- History of gastrointestinal bleeding or intracranial hemorrhage in the past 6 weeks.
- Stroke or head injury in the past 3 months
- On-going therapeutic anticoagulants that could not be interrupted (except prophylactic heparin treatment that can be continued）
- Any history of Chronic liver disease with a Child score B or C
- Any condition at risk of bleeding, as appreciated by the physician in charge of the patient
- Severe anemia (hemoglobin \<5.9 g/dL)
Key Trial Info
Start Date :
January 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04898322
Start Date
January 2 2022
End Date
July 1 2023
Last Update
March 14 2022
Active Locations (1)
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1
Zhongda Hospital，Affiliated to Southeast University
Nanjing, Jiangsu, China