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Status unknownNCT06548854SepsisUpdated Aug 12, 2024

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploration Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetic Characteristics of STC314 Injection Administered Intravenously in Sepsis Patients

A Phase 2 interventional study of STC314 Injection/STC314 Injection Placebo in Sepsis, sponsored by Grand Medical Pty Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Grand Medical Pty Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Nov 2023, registered Aug 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

One study evaluated the efficacy and safety of intravenous STC314 injection in patients with sepsis Sex and pharmacokinetic profiles of a multicenter, randomized, double-blind, placebo-controlled II Phase I dose exploration clinical trial

Read the detailed description

This is a randomized, double-blind, placebo-controlled phase II dose exploration study. The aim of this trial is to evaluate the efficacy, safety, and pharmacokinetic characteristics of STC314 injection in sepsis patients receiving loading dose and continuous intravenous infusion, determine the optimal therapeutic dose, and provide supporting evidence for phase III clinical trials. The overall design of the experiment is shown in Figure 1. This experiment consists of three parallel groups, including two treatment groups with different doses of STC314 injection and one placebo control group.

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Conditions studied

  • Sepsis

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Keywords

  • sepsis
03

In context

Sepsis

1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.

This study's planned enrollment of 180 is above the median of 105 across 918 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Grand Medical Pty Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (1) 18≤ age ≤80 years old, gender is not limited; (2) The subjects or their guardians voluntarily participate in the study and sign the informed consent; (3) being treated in an intensive care unit; (4) Meet the diagnostic criteria for sepsis 3.0, namely:

    1. There is a confirmed or suspected infection;
    2. The presence of infection-induced organ dysfunction, i.e., the Sequential Organ failure score (SOFA) ≥2, as known in If there is organ function impairment before infection, that is, SOFA score is greater than 0, it is necessary to compare SOFA score after infection Previous rise ≥2 points. (5) SOFA score ≤ 13 points; (6) The time from meeting the sepsis 3.0 diagnostic criteria to randomization does not exceed 48 hours; (7) Male and female subjects of reproductive age agreed to use an effective contraceptive method from the start of the study until 1 month after the end of dosing.

Exclusion criteria

Exclusion Criteria:

  • (1) The pregnancy test of women of childbearing age before administration is positive, and pregnant or lactating women; (2) Chronic disease has caused serious organ function impairment, or has caused serious complications:

    1. Heart: New York Heart Association Heart Function Grade IV;
    2. Lung: chronic respiratory failure requires long-term oxygen therapy;
    3. Kidney: chronic kidney disease stage 4 or 5;
    4. Liver: previous liver failure, hepatic encephalopathy or hepatic coma, gastrointestinal bleeding caused by portal hypertension in the past six months; Or Child-Pugh score ≥ 10 points. (3) Cancer patients with cachexia, or due to obstruction, space occupation, extrusion and other reasons, resulting in serious damage to organ function or internal bleeding, Those who have difficulty or have not yet undergone surgical treatment, or who have received chemotherapy or immunotherapy within the last month; (4) The subjects had severe immune deficiency or were using strong immunosuppression: granulocytosis (N\<0.5×10\^9/L), activity Blood tumor or stage III HIV infection; Are being treated with immune-inducing drugs such as anti-thymocyte globulin (ATG), Antilymphocyte globulin (ALG), interleukin-2 receptor a chain antibody (IL-2RA), and interleukin-6 receptor αantibody (IL-6RA), etc. Continuous use of glucocorticoid therapy for nearly 2 weeks with a daily dose exceeding 200mg equivalent to hydrocortisone; (5) There is active bleeding that is difficult to control effectively; (6) Currently requiring systemic administration of therapeutic doses of anticoagulants (except prophylactic doses); (7) aPTT > 1.5 times the upper limit of normal value; (8) Platelet count \< 50 ×10\^9/L; (9) The patient needs or is receiving extracorporeal membrane oxygenation (ECMO) treatment; (10) endangered status, the expected survival time is not more than 24 hours; (11) Cardiac arrest, acute myocardial infarction, or massive cerebral infarction in the past 1 week; (12) are receiving or require dialysis or kidney replacement treatment within 6 hours; (13) Combined with severe or more severe burns: the total surface area of the burn exceeds 30% or the area of the third-degree burn exceeds 10%; Or surface Less than 30% of the volume, but the body condition is heavier or have shock, compound injury, respiratory tract burning; (14) Allergic to the active ingredient of the test drug (methylcellobiose sulfate) or excipients (disodium hydrogen phosphate and sodium dihydrogen phosphate); (15) Participants had participated in another clinical study (except those who did not receive intervention) or were participating in another trial within 1 month prior to screening Clinical treatment; (16) The subject's previous or ongoing disease, physical examination or laboratory test results are abnormal, as determined by the investigator to be probable Adversely affect the subject's safety in the study, or may affect the assessment of the subject's clinical or mental state By a wide margin.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    High dose group

    The experimental drug was administered intravenously for 5 days

    Drug: STC314 Injection/STC314 Injection Placebo

  • Experimental
    low dose group

    The experimental drug was administered intravenously for 5 days

    Drug: STC314 Injection/STC314 Injection Placebo

  • Placebo comparator
    Placebo

    Placebo infusion continued for 5 days

    Drug: STC314 Injection/STC314 Injection Placebo

Interventions

  • DrugSTC314 Injection/STC314 Injection Placebo

    All subjects who meet the inclusion criteria and do not meet the exclusion criteria will be randomly assigned to receive continuous intravenous infusion of STC314 injection (dose in salt form) or placebo with continuous intravenous infusion of the same volume load infusion for 5 days at an overall ratio of 1:1:1.

    Also known as: STC314 Injection Placebo

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What researchers measure

Primary outcomes

  1. Changes in sequential organ failure (SOFA) scores from baseline on day 7 value

    Changes in sequential organ failure (SOFA) scores from baseline on day 7 value

    Time frame: 7 days after the first dose

07

Study locations

1 site
  • Zhongda Hospital Southeast University
    Nanjing, Jiangsu 210009, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2023 (actual). Primary completion is estimated for Nov 2024, 12 months after the start.

Of 46 phase 2 interventional studies under Sepsis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 35. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2024
First posted
Aug 12, 2024
StartActual
Nov 20, 2023
Primary completionEst.
Nov 30, 2024
CompletionEst.
Feb 28, 2025
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06548854
Lead sponsor
Grand Medical Pty Ltd.
Responsible party
Sponsor
First posted
Aug 12, 2024
Start date
Nov 20, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Aug 12, 2024

Study contacts

Gang Wu, PM
study director · GrandPharma (China) Co., Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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