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Trial registered on ANZCTR


Registration number
ACTRN12620000716965
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
2/07/2020
Date last updated
2/07/2020
Date data sharing statement initially provided
2/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Open Label Study to Determine the Safety, Tolerability and Pharmacokinetics of STC3141 Administered as an Infusion for up to 72 hours in Subjects in an Intensive Care Unit
Scientific title
A Dose Adjusted, Open Label, Multi-Centre Study to Determine the Safety, Tolerability and Pharmacokinetics of STC3141 Administered as an Infusion for up to 72 hours in Subjects with Sepsis and Normal or Compromised Renal Function in an Intensive Care Unit
Secondary ID [1] 301136 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 317503 0
Condition category
Condition code
Inflammatory and Immune System 315601 315601 0 0
Other inflammatory or immune system disorders
Infection 315602 315602 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study drug is STC3141. The Investigator is responsible for the education of study staff as to the correct administration of the study drug. Once the study drug has been assigned to a subject it must not be reassigned to another subject. The study drug will be administered as a continuous IV infusion for up to 72 hours and shall be given as 3 x 100mLvolume sequentially over 24 hours via a dedicated infusion line. Each 100mL of study drug will be prepared daily in a bag, prior to use. An infusion pump set to a rate of 4.0 mL/hr will be used to administer the study drug.
Four target steady state plasma concentrations (Css) are planned: 5µg/ml, 10µg/ml, 20 µg/mL and 25 µg/mL. (This is a pharmacokinetic guided design, so the infusion rate of each patients can be varied, which will be calculated based on their CrCL. This is a dose ascending study, with sequential cohorts only commencing upon satisfactory completion of the previous cohort.
A subject may remain in the study but discontinue the infusion, at any time during treatment. Reason may include:
• Protocol deviations or subject non compliance (must be specified on the appropriate eCRF)
• Serious or severe AEs
• Administrative decision by the Investigator or the Sponsor
• Death
• The subject is discharged from ICU
• The subject requires a therapeutic heparin infusion to be commenced
• The condition of the subject deteriorates to the point that active treatment is withdrawn
• It is not in the subject’s best interests for the infusion to continue at the Investigators’ discretion
• Withdrawal of consent by subject or their legal representatives

Intervention code [1] 317614 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323841 0
Incidence of AE and SAEs by severity graded by CTCAE 5.0
Timepoint [1] 323841 0
Day 8 post start-of-infusion
Primary outcome [2] 323842 0
Incidence of treatment discontinuation due to AEs by data linked to discontinuation
Timepoint [2] 323842 0
Day 8 post start-of-infusion
Secondary outcome [1] 383037 0
Plasma PK parameters including Cmax, Tmax, Kel, AUC0-t, AUC0-inf, t1/2, CL, AUMC0-t, AUMC0-inf, MRT, Vss,
Timepoint [1] 383037 0
Blood samples for PK analysis will be collected within 2 hours prior to the start of the IP infusion, and at 12, 24 and 48 hours (±30 minutes) from the start of infusion, within 10 minutes before the EOI and 1(±2 minutes), 6 and 12 (±10 minutes), 24, 48, 72 and 120 hours (±30 minutes) post infusion.
Secondary outcome [2] 383777 0
Urine PK parameters including Ae0-t, fe and CLr.
Timepoint [2] 383777 0
All urine excreted by each subject will be collected for urine PK analysis, pooled, and the volume measured at the following intervals: a spot sample within 2 hours prior to the start of the IP infusion, and at 0-12, 12-24, 24-48, 48-72, 72-96, 96-120, and 120-144 hours from the start of infusion. At the end of each collection interval, record the total volume of sample pooled. Promptly mix pooled urine thoroughly and use a disposable plastic pipette to transfer at least 1 mL of sample into two 1.8 mL cryotubes (one A aliquot, one B aliquot).

Eligibility
Key inclusion criteria
1..Aged 18 to 80 years (inclusive at the time of informed consent);
2..Confirmed or suspected infection originating from any source with the exception of the urinary tract;
3..Initiation of antibiotics;
4..Subjects with the sepsis-associated organ dysfunction as identified by a total Sequential Organ Failure Assessment (SOFA) score greater or equal 2 points;
5. Lactate is between 2mmol/L and 6 mmol/L at the time of screening.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who will likely require surgery within 72 hours;
2. Subjects who require a therapeutic dose of heparin or who are receiving oral anticoagulants, or received warfarin, factor Xa inhibitors within last 24 hours;
3. Subjects who have Absolute Neutrophil Count (ANC) less than 1000/mL;
4. Subjects who have activated Partial Thromboplastin Time (aPTT) greater than 55 s;
5. Severe anaemia (haemoglobin <less than 7.0 g/dL);
6. Bleeding in the past 24 hours requiring blood transfusion;
7. Large area thermal burns or chemical burns (III-degree burns area greater than 30% Body Surface Area);
8. Solid organ or bone marrow transplantation within 4 weeks;

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
dose escalation
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 305577 0
Commercial sector/Industry
Name [1] 305577 0
Grand Medical
Address [1] 305577 0
Shop 6 / 207 Pacific Hwy
St Leonards, NSW 2065
Country [1] 305577 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Grand Medical Pty Ltd
Address
Shop 6 / 207 Pacific Hwy
St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 306189 0
None
Name [1] 306189 0
Address [1] 306189 0
Country [1] 306189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305879 0
AUSTIN HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 305879 0
145 Studley Road,
PO Box 5555 Heidelberg.
Victoria Australia 3084
Ethics committee country [1] 305879 0
Australia
Date submitted for ethics approval [1] 305879 0
Approval date [1] 305879 0
29/04/2020
Ethics approval number [1] 305879 0

Summary
Brief summary
Septic patients often present renal dysfunction,, while it is important to figure it out the safety coverage and dose adjustment for these patients. This is a dose-adjusted, open-label, multi-centre study to determine the safety, tolerability and PK of STC3141 administered as a continuous IV infusion of up to 72 hours in subjects with sepsis and normal or compromised renal function in an ICU, where the rate of infusion is adjusted to account for calculated creatinine clearance. Four target steady state plasma concentrations (Css) are planned: 5µg/ml, 10µg/ml, 20 µg/mL and 25 µg/mL. Up to a total of 26 subjects will be enrolled into four (4) cohorts in the study, but numbers will depend on dose escalation/expansion decisions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101910 0
Prof Rinaldo Bellomo
Address 101910 0
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084
Country 101910 0
Australia
Phone 101910 0
+61 3 9496 5000
Fax 101910 0
Email 101910 0
ethics@austin.org.au
Contact person for public queries
Name 101911 0
Dr Dorothy Li
Address 101911 0
Grand Medical Pty Ltd
Shop 6 / 207 Pacific Hwy
St Leonards, NSW 2065
Country 101911 0
Australia
Phone 101911 0
+61 450525760
Fax 101911 0
Email 101911 0
lining@grandpharma.cn
Contact person for scientific queries
Name 101912 0
Dr Dorothy Li
Address 101912 0
Grand Medical Pty Ltd
Shop 6 / 207 Pacific Hwy
St Leonards, NSW 2065
Country 101912 0
Australia
Phone 101912 0
+61 450525760
Fax 101912 0
Email 101912 0
lining@grandpharma.cn

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD was not planned to be shared
What supporting documents are/will be available?
No other documents available
Summary results
No Results