Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients

Tianjin Chase Sun Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Sepsis

Treatments: Drug: 16mg，KB; Drug: Placebos

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04803955

HR-KB201

Details and patient eligibility

About

Phase II study of Kukoamine B Mesilate in Sepsis Patients

Full description

To Assess Efficacy,Safety,Pharmacokinetics of Kukoamine B Mesilate in Sepsis Patients

Enrollment: 424 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) The age of ≥ 18 years of age and ≤ 85 years of age, gender is not limited;
• (2) Meeting the diagnostic criteria for sepsis 3.0, i.e. sequential organ failure score (SOFA) increased by ≥2 points from baseline for patients with confirmed or suspected infection;
• (3) Confirmed or suspected bacterial infection (Pulmonary, abdominal，urinary system or hematogenous infections);
• (4) Infection-related organ failure does not exceed 48 hours; organ failure is defined as circulation, (SOFA) ≥ 3 points in at least one organ or system of the respiratory, kidney, liver, coagulation and central nervous system;
• (5) Childbearing age within six months without child care plan and agreed to take effective measures during the study of contraception;
• (6) Patients or guardians signed informed consent.

Exclusion criteria

• (1) Pregnancy or lactation women；
• (2) Patients are expected to live less than 48 hours;
• (3) Patients had poor control of malignant tumor, end-stage lung disease and other end-stage diseases, or had acardiac arrest，acute pulmonary embolism，blood transfusion response and acute coronary syndrome within 4 weeks prior to enrollment;
• (4) The patient has the following chronic organ dysfunction or immunosuppression (based on the chronic health scoring assessment of the APACHE II score) : 1) heart: New York heart association cardiac function IV; 2) breathing: chronic obstructive, obstructive, or vascular lung disease can lead to severe restrictions on activities, i.e. the inability to go upstairs or to do housework; Or clear chronic hypoxia, CO2 retention, secondary real erythrocyte, severe pulmonary hypertension (mPAP> 40 mmHg) or respiratory muscle dependence; 3) kidneys: receiving long-term dialysis; 4) liver: liver cirrhosis confirmed by biopsy and clear portal hypertension; The upper digestive tract hemorrhage caused by portal hypertension; Or previous liver failure/hepatic encephalopathy/hepatic coma; 5) of immune function: accept the treatment of impact resistance to infection, such as immune suppression therapy, chemotherapy, radiotherapy or chemotherapy within 6 months, long-term (continuous use ≥3 weeks) use of glucocorticoids or recent (within 5 days before screening) cumulative use of prednisone or equivalent dose ≥100mg , or sickness impact resistance to infection, such as leukemia, lymphoma and AIDS);
• (5) Previous solid organ or bone marrow transplantation;
• (6) Plant survival status;
• (7) Confirmed or highly suspected of acute infectious diseases such as viral hepatitis activity , or clinically confirmed active tuberculosis;
• (8) Patients with sinus bradycardia (less than 60 per minute);
• (9) Uncontrolled bleeding in the past 24 hours（Clinical judgment requires transfusion support）;
• (10) Large area burns or chemical burns (III degree burns area > 30% BSA);
• (11) The average arterial pressure was < 65 mmHg after adequate liquid resuscitation and vasoactive drug therapy;
• (12) Acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (ANC < 500 / mm3);
• (13) Allergic to the active ingredient or its auxiliary materials;
• (14) The medication patients are using may severely affect the metabolism of the drug;
• (15) Patients and (or) guardians have signed a Do Not Rescue (DNR), or decided to withdraw life support (withdraw) or restrict life support for the intensity (withhold) and sign the informed consent form;
• (16) Participated in clinical intervention test in 3 months;
• (17) The subject is a researcher or his immediate family member, or may have improper informed consent;
• (18) The investigator considers it inappropriate for the patient to participate in this test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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424 participants in 2 patient groups, including a placebo group

16mg,KB

Experimental group

Description:

Group A:16mg,Q8h±3min,Day1-Day7

Treatment:

Drug: 16mg，KB

Placebos

Placebo Comparator group

Description:

Group B:Placebos,Q8h±3min,Day1-Day7

Treatment:

Drug: Placebos