Back to resultsSY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
Primary Purpose
Sepsis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SY-005
SY-005
SY-005
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
Eligibility 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:
- 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)
Sites / Locations
- Zhongda Hospital，Affiliated to Southeast UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
2.5mg SY-005
5mg SY-005
10mg SY-005
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Safety and Tolerability Parameters of SY-005
Number of patients with treatment-emergent adverse events over 28 days
Secondary Outcome Measures
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 1, Day3, Day5, Day7
Vasopressin Free Days From Day 0 to Day 28
Assessment of ICU-Free Days From Day 0 to Day 28
Ventilator-Free Days From Day 0 to Day 28
7-Day and 28-Day Mortality
Change From Baseline in IL-1β at Day 3，Day5
Change From Baseline in IL-6 at Day 3，Day5
Change From Baseline in Procalcitonin at Day 3，Day5
Change From Baseline in Prothrombin Time at Day 3，Day5
Change From Baseline in Thrombin Time at Day 3，Day5
Change From Baseline in Activated Partial Thromboplastin Time at Day 3，Day5
Change From Baseline in Fibrinogen at Day 3，Day5
Change From Baseline in Chemokine(C-C motif) Ligand 2 at Day 3，Day5
Change From Baseline in Anti-drug Antibodies at Day7，Day14，Day28
Full Information
NCT ID
NCT04898322
First Posted
May 11, 2021
Last Updated
February 27, 2022
Sponsor
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04898322
Brief Title
SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Yabao Pharmaceutical R&D Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2.5mg SY-005
Arm Type
Experimental
Arm Title
5mg SY-005
Arm Type
Experimental
Arm Title
10mg SY-005
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SY-005
Intervention Description
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Intervention Type
Drug
Intervention Name(s)
SY-005
Intervention Description
5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Intervention Type
Drug
Intervention Name(s)
SY-005
Intervention Description
10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Safety and Tolerability Parameters of SY-005
Description
Number of patients with treatment-emergent adverse events over 28 days
Time Frame
From Day 0 to Day 28
Secondary Outcome Measure Information:
Title
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 1, Day3, Day5, Day7
Time Frame
Baseline, Day 1, Day3, Day5, Day7
Title
Vasopressin Free Days From Day 0 to Day 28
Time Frame
From Day 0 to Day 28
Title
Assessment of ICU-Free Days From Day 0 to Day 28
Time Frame
From Day 0 to Day 28
Title
Ventilator-Free Days From Day 0 to Day 28
Time Frame
From Day 0 to Day 28
Title
7-Day and 28-Day Mortality
Time Frame
Over 7/28 Days Following First Dose
Title
Change From Baseline in IL-1β at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in IL-6 at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in Procalcitonin at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in Prothrombin Time at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in Thrombin Time at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in Activated Partial Thromboplastin Time at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in Fibrinogen at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in Chemokine(C-C motif) Ligand 2 at Day 3，Day5
Time Frame
Baseline, Day 3，Day5
Title
Change From Baseline in Anti-drug Antibodies at Day7，Day14，Day28
Time Frame
Baseline, Day7，Day14，Day28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang
Phone
+86 025-83272015
Email
yiyiyang2004@163.com
Facility Information:
Facility Name
Zhongda Hospital，Affiliated to Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
We'll reach out to this number within 24 hrs