Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients

NCT04803955 | Recruiting Phase 2

• 1 other identifier: HR-KB201
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II study of Kukoamine B Mesilate in Sepsis Patients

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Delta SOFA (ΔSOFA)

  Change in SOFA scale from baseline.

  Day 8 after the first dose (Within 24 hours after the last dose on day 7)

Secondary Outcomes (8)

• Clinical Outcome Composite Endpoint

  28 days after the first dose

• Proportion of patients with 7-day all-cause deaths

  7 days after the first dose

• Proportion of patients transferred out of ICU

  7 days after the first dose

• Quantification of IL-6

  Day 2, 4 , 8 after the first dose (Within 24 hours after the last dose on day 7)

• Delta SOFA (ΔSOFA)

  Day 1, 3, 5 after the first dose

Other Outcomes (5)

• Area under the curve at steady state (AUCss)

  Day 1 and Day 7

• Peak plasma concentration at steady state (Cmaxss)

  Day 1 and Day 7

• Trough plasma concentration at steady state (Cminss)

  Day 1 and Day 7

Study Arms (2)

16mg,KB

EXPERIMENTAL

Group A:16mg,Q8h±3min,Day1-Day7

Drug: 16mg，KB

Placebos

PLACEBO COMPARATOR

Group B:Placebos,Q8h±3min,Day1-Day7

Drug: Placebos

Interventions

16mg，KB DRUG

16mg,Q8h±3min,Day1-Day7

16mg,KB

Placebos DRUG

16mg,Q8h±3min,Day1-Day7

Placebos

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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;

Sponsors & Collaborators

• Tianjin Chasesun Pharmaceutical Co., LTD: lead
• Southwest Hospital, China: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shuai Chen, Bachelor

CONTACT

+86 022-59623160; 18600050139@126.com

Bin Du, Doctor

CONTACT

+86 010-69155036; dubin98@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: May 15, 2021
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CN (1)