Patients admitted to the ICU for the treatment of sepsis Sepsis
Conditions
Interventions
Participants will receive isupartob sodium administered as a continuous intravenous infusion at low dose for up to 120 hours.,Participants will receive isupartob sodium administered as a continuous in
Experimental Drug,Experimental Drug,Experimental Drug,Placebo Comparator Drug,Experimental Drug,Placebo Comparator Drug
Isupartob sodium low dose (Part A),Isupartob sodium medium dose (Part A),Isupartob sodium high dose (Part A),Placebo (Part A),Isupartob sodium (Part B),Placebo (Part B)
Sponsors
Matisse Pharmaceuticals B.V.
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Male or female, aged 18-85 years at time of informed consent 3. Body weight 45 kg - 120 kg 4. ICU admittance for sepsis defined by the Sepsis-3 criteria (SOFA-2 score of more than or equal to 2) 5. Female subjects must have a negative serum pregnancy test and must be willing and able to adhere to contraceptive requirements
Exclusion criteria
Exclusion criteria: 1. Solid organ, allogeneic bone marrow, or stem cell transplantation within 6 months prior to consent 2. Active hematological or oncological malignancy 3. Severe neutropenia 4. Severe hepatic impairment or abnormal liver function 5. Burned more than 30% of body surface 6. Increased bleeding risk 7. Use of anticoagulant treatment with heparin sodium, high dose of low molecular weight heparins (LMWH), warfarin, thrombolytic therapy, IIb/IIIa inhibitors, or direct acting anticoagulants 8. Known severe adverse reaction to heparin sodium 9. Breastfeeding 10. Participation in any interventional clinical study within 4 weeks or 5 half-lives before consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum interleukin-6 level baseline and 24 hours Percent change in serum levels of IL-6,Serum C-reactive protein level baseline and 48 hours Percent change in serum levels of CRP,Sequential Organ Failure Assessments 2 score baseline and end of treatment Change in SOFA-2 score | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events the time of study drug administration through the end of study (Day 90) Occurrence of TEAEs,Clinical laboratory tests baseline through end of treatment (Day 7) Change in clinical laboratory tests (chemistry, hematology, coagulation),Vital signs baseline through follow-up 1 (Day 35) Changes in vital signs,Electrocardiogram parameters baseline through end of treatment (Day 7) Changes in ECG parameters,Serum interleukin-6 and C-reactive protein levels baseline and pre-specified timepoints Percent Change in serum levels of IL-6 and CRP,Sequential Organ Failure Assessments 2 score baseline and pre-specified timepoints Change in SOFA-2 score,Organ Support Free days Over 28 days Amount of advanced ventilatory support or ECMO free days, Vasopressor support free days, and Renal replacement therapy free days,Intensive care unit free days Over 28 days Amount of ICU free days,All-cause mortality At day 28 Survival status,All-cause mortality At day 90 Survival status,Cell free histones H3 and H2b baseline and pre-specified timepoints Percent change in plasma levels of cell free histones H3 and H2b,Plasma levels of isupartob baseline through end of treatment (Day 7) Cmax, Css, tmax, AUC, CL, t1/2, Vz,Urine levels of isupartob Last day of dosing (Day 5 to 6) Absolute amount excreted in 24h, amount excreted as percentage of the administered dose over such interval | — |
Countries
Thailand
Contacts
Public ContactTanja van Viegen
Matisse Pharmaceuticals B.V.
Outcome results
None listed