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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04898322
Other study ID # SY005002
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 2, 2022
Est. completion date July 1, 2023

Study information

Verified date February 2022
Source Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Contact Yi Yang
Phone +86 025-83272015
Email yiyiyang2004@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SY-005
2.5mg of SY-005 for each dose,doses to be given every 12 hours over a period of 5 days
SY-005
5mg of SY-005 for each dose,doses to be given every 12 hours over a period of 5 days
SY-005
10mg of SY-005 for each dose,doses to be given every 12 hours over a period of 5 days
Placebo
Placebo

Locations

Country Name City State
China Zhongda Hospital,Affiliated to Southeast University Nanjing Jiangsu

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

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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