SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
NCT ID: NCT04898322
Last Updated: 2022-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
96 participants
INTERVENTIONAL
2022-01-02
2023-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2.5mg SY-005
SY-005
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
5mg SY-005
SY-005
5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
10mg SY-005
SY-005
10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Placebo
Placebo
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Suzhou Yabao Pharmaceutical R&D Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Zhongda Hospital，Affiliated to Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Yi Yang
Role: primary
Other Identifiers
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SY005002
Identifier Type: -
Identifier Source: org_study_id
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