SepsisPhase 2NCT04898322
SY-005 （Recombinant Human Annexin A5）in Patients With Sepsis
A Phase 2 study testing SY-005 in people with Sepsis, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- What is being tested?
- SY-005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2022to 1 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital，Affiliated to Southeast University
Nanjing, Jiangsu
Yi Yang
About this study
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
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.
- Conditions
- Sepsis
- Being tested
- SY-005, Placebo
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SY-005Drug
2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
SY-005Drug
5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
SY-005Drug
10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2.5mg SY-005 | Experimental | Not described Receives: Drug: SY-005 |
| 5mg SY-005 | Experimental | Not described Receives: Drug: SY-005 |
| 10mg SY-005 | Experimental | Not described Receives: Drug: SY-005 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Parameters of SY-005
Number of patients with treatment-emergent adverse events over 28 days
Measured: From Day 0 to Day 28
Secondary outcomes (14)
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 1, Day3, Day5, Day7
Measured: Baseline, Day 1, Day3, Day5, Day7
Vasopressin Free Days From Day 0 to Day 28
Measured: From Day 0 to Day 28
Assessment of ICU-Free Days From Day 0 to Day 28
Measured: From Day 0 to Day 28
Ventilator-Free Days From Day 0 to Day 28
Measured: From Day 0 to Day 28
7-Day and 28-Day Mortality
Measured: Over 7/28 Days Following First Dose
Change From Baseline in IL-1β at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in IL-6 at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in Procalcitonin at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in Prothrombin Time at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in Thrombin Time at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in Activated Partial Thromboplastin Time at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in Fibrinogen at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in Chemokine(C-C motif) Ligand 2 at Day 3，Day5
Measured: Baseline, Day 3，Day5
Change From Baseline in Anti-drug Antibodies at Day7，Day14，Day28
Measured: Baseline, Day7，Day14，Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start2 Jan 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898322
- Sponsor's protocol ID
- SY005002
- Status last verified
- Feb 2022
- First submitted
- 11 May 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04898322
- Acronym / sponsor ID
- SY005002
- Conditions
- Sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2.5mg SY-005 | Experimental | Drug: SY-005 |
| 5mg SY-005 | Experimental | Drug: SY-005 |
| 10mg SY-005 | Experimental | Drug: SY-005 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SY-0052.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days | Drug | 2.5mg SY-005 |
| SY-0055mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days | Drug | 5mg SY-005 |
| SY-00510mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days | Drug | 10mg SY-005 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
14 secondary outcomes
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 1, Day3, Day5, Day7
Time frame: Baseline, Day 1, Day3, Day5, Day7
Vasopressin Free Days From Day 0 to Day 28
Time frame: 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
Ventilator-Free Days From Day 0 to Day 28
Time frame: From Day 0 to Day 28
7-Day and 28-Day Mortality
Time frame: Over 7/28 Days Following First Dose
Change From Baseline in IL-1β at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in IL-6 at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in Procalcitonin at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in Prothrombin Time at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in Thrombin Time at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in Activated Partial Thromboplastin Time at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in Fibrinogen at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in Chemokine(C-C motif) Ligand 2 at Day 3，Day5
Time frame: Baseline, Day 3，Day5
Change From Baseline in Anti-drug Antibodies at Day7，Day14，Day28
Time frame: Baseline, Day7，Day14，Day28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SY-005 in people with Sepsis, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang (+86 025-83272015, yiyiyang2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Parameters of SY-005 (time frame: From Day 0 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.