Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

NCT03237728 | Completed Phase 1

• 1 other identifier: HR-KB104
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  AE, physical examination, monitoring of vital signs, Laboratory examination etc.

  Day-1 to Day8

Study Arms (4)

0.06mg/kg,KB and Placebo

EXPERIMENTAL

Group A:0.06mg/kg,Q8h,Day1-Day7

Drug: 0.06mg/kg,KB; Drug: Placebos

0.12mg/kg,KB

EXPERIMENTAL

Group B:0.12mg/kg,Q8h,Day1-Day7

Drug: 0.12mg/kg,KB

0.24mg/kg,KB

EXPERIMENTAL

Group C:0.24mg/kg,Q8h,Day1-Day7

Drug: 0.24mg/,KB

Placebos

EXPERIMENTAL

Group D:Placebos,Q8h,Day1-Day7

Drug: Placebos

Interventions

0.06mg/kg,KB DRUG

0.06mg/kg,Q8h,Day1-Day7

0.06mg/kg,KB and Placebo

0.12mg/kg,KB DRUG

0.12mg/kg,Q8h,Day1-Day7

0.12mg/kg,KB

0.24mg/,KB DRUG

0.24mg/kg,Q8h,Day1-Day7

0.24mg/kg,KB

Placebos DRUG

Placebos,Q8h,Day1-Day7

0.06mg/kg,KB and Placebo; Placebos

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age of ≥ 18 years of age and ≤ 70 years of age, gender is not limited;
• Confirmed or suspected bacterial infection (refer to Appendix 5);
• Infection-related organ failure does not exceed 24 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;
• The time interval between the selection of the test drug and the test drug is not more than 8 hours;
• Infertility test for women of childbearing age;
• Childbearing age within six months without child care plan and agreed to take effective measures during the study of contraception;
• Patients or legal representatives signed informed consent.

You may not qualify if:

• Pregnant or lactating women, or unable to take effective measures of contraception;
• Patients are expected to live less than 28 days due to basic diseases, such as poor control of malignant tumor, cardiac arrest in 30 days, and end-stage lung disease.
• The patient has the following chronic organ dysfunction or immunosuppression (based on the chronic health scoring assessment of the APACHE II score) : a) heart: New York heart association cardiac function IV; B) 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 (\> 40 mmHg) or respiratory muscle dependence; C) kidneys: receiving long-term dialysis; D) 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; E) of immune function: accept the treatment of impact resistance to infection, such as immune suppression therapy, chemotherapy, radiation therapy, or for a long time the recent use of high doses of hormones), or sickness impact resistance to infection, such as leukemia, lymphoma and AIDS);
• Solid organ or bone marrow transplantation;
• Plant survival status;
• The following conditions occurred within 4 weeks prior to infection: a) acute pulmonary embolism; B) transfusion response; C) acute coronary syndrome;
• Confirmed or highly suspected of acute infectious diseases such as viral hepatitis activity and active tuberculosis;
• Patients with sinus bradycardia (less than 60 per minute);
• Severe anemia (hemoglobin \< 7.0 g/dL);
• Uncontrolled bleeding in the past 24 hours;
• Large area burns or chemical burns (III degree burns area \> 30% BSA);
• The average arterial pressure was \< 65 mmHg after adequate liquid resuscitation and vasoactive drug therapy.
• Acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (ANC \< 500 / mm3), or severe thrombocytopenia (\< 20,000 / mm3);
• Allergic to the active ingredient or its auxiliary materials;
• The medication patients are using may severely affect the metabolism of the drug;

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

Location

Related Publications (1)

• Hu XY, Zhang W, Wang D, Sun Y, Hu Z, Zang B, Feng Y, Wang H, Zhou J, Zhao Q, Liu H, Wang T, Jiang W, Wang CY, Jin C, Dong K, Chen S, Yao X, Hu P, Du B; China Critical Care Clinical Trials Group (CCCCTG). Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial. J Crit Care. 2023 Aug;76:154294. doi: 10.1016/j.jcrc.2023.154294. Epub 2023 Apr 26.

  PMID: 37116228 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: July 31, 2017
• First Posted: August 2, 2017
• Study Start: July 28, 2017
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: January 22, 2020

Record last verified: 2019-04

Locations

CN (1)