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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898322
• Other study ID #: SY005002
• Status: Recruiting
• Phase: Phase 2
• 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
• 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)

Related Conditions & MeSH terms

• Sepsis
• Toxemia

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