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

February 27, 2022 updated by: Suzhou Yabao Pharmaceutical R&D Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital,Affiliated to Southeast University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: 2.5mg SY-005
Drug: SY-005
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Drug: SY-005
5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Drug: SY-005
10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Experimental: 5mg SY-005
Drug: SY-005
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Drug: SY-005
5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Drug: SY-005
10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Experimental: 10mg SY-005
Drug: SY-005
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Drug: SY-005
5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
Drug: SY-005
10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and Tolerability Parameters of SY-005
Time Frame: From Day 0 to Day 28
Number of patients with treatment-emergent adverse events over 28 days
From Day 0 to Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 1, Day3, Day5, Day7
Time Frame: Baseline, Day 1, Day3, Day5, Day7
Baseline, Day 1, Day3, Day5, Day7
Vasopressin Free Days From Day 0 to Day 28
Time Frame: From Day 0 to Day 28
From Day 0 to Day 28
Assessment of ICU-Free Days From Day 0 to Day 28
Time Frame: From Day 0 to Day 28
From Day 0 to Day 28
Ventilator-Free Days From Day 0 to Day 28
Time Frame: From Day 0 to Day 28
From Day 0 to Day 28
7-Day and 28-Day Mortality
Time Frame: Over 7/28 Days Following First Dose
Over 7/28 Days Following First Dose
Change From Baseline in IL-1β at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in IL-6 at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in Procalcitonin at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in Prothrombin Time at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in Thrombin Time at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in Activated Partial Thromboplastin Time at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in Fibrinogen at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in Chemokine(C-C motif) Ligand 2 at Day 3，Day5
Time Frame: Baseline, Day 3，Day5
Baseline, Day 3，Day5
Change From Baseline in Anti-drug Antibodies at Day7，Day14，Day28
Time Frame: Baseline, Day7，Day14，Day28
Baseline, Day7，Day14，Day28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suzhou Yabao Pharmaceutical R&D Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SY005002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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