Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

January 19, 2020 updated by: Tianjin Chasesun Pharmaceutical Co., LTD

Randomized, Double-blind Placebo-controlled Clinical Study to Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of Multiple-dose Kukoamine B Mesilate in Sepsis Patients

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B Mesilate in Sepsis Patients

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The age of ≥ 18 years of age and ≤ 70 years of age, gender is not limited;
  2. Confirmed or suspected bacterial infection (refer to Appendix 5);
  3. 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;
  4. The time interval between the selection of the test drug and the test drug is not more than 8 hours;
  5. Infertility test for women of childbearing age;
  6. Childbearing age within six months without child care plan and agreed to take effective measures during the study of contraception;
  7. Patients or legal representatives signed informed consent.

Exclusion Criteria:

  1. Pregnant or lactating women, or unable to take effective measures of contraception;
  2. 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.
  3. 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);
  4. Solid organ or bone marrow transplantation;
  5. Plant survival status;
  6. The following conditions occurred within 4 weeks prior to infection: a) acute pulmonary embolism; B) transfusion response; C) acute coronary syndrome;
  7. Confirmed or highly suspected of acute infectious diseases such as viral hepatitis activity and active tuberculosis;
  8. Patients with sinus bradycardia (less than 60 per minute);
  9. Severe anemia (hemoglobin < 7.0 g/dL);
  10. Uncontrolled bleeding in the past 24 hours;
  11. Large area burns or chemical burns (III degree burns area > 30% BSA);
  12. The average arterial pressure was < 65 mmHg after adequate liquid resuscitation and vasoactive drug therapy.
  13. Acute myeloid hematopoiesis was characterized by a lack of severe granulocytes (ANC < 500 / mm3), or severe thrombocytopenia (< 20,000 / mm3);
  14. Allergic to the active ingredient or its auxiliary materials;
  15. The medication patients are using may severely affect the metabolism of the drug;
  16. Patients and (or) legal representatives have signed an unresuscitation (DNR), or decided to withdraw life support (withdraw) or restrict life support for the intensity (of the patient) and sign the informed consent form;
  17. Participated in clinical intervention test in 3 months;
  18. The subject is a researcher or his immediate family member, or may have improper informed consent;
  19. The attending physician considers it inappropriate for the patient to participate in this test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 0.06mg/kg,KB and Placebo
Group A:0.06mg/kg,Q8h,Day1-Day7
Drug: 0.06mg/kg,KB
0.06mg/kg,Q8h,Day1-Day7
Drug: Placebos
Placebos,Q8h,Day1-Day7
EXPERIMENTAL: 0.12mg/kg,KB
Group B:0.12mg/kg,Q8h,Day1-Day7
Drug: 0.12mg/kg,KB
0.12mg/kg,Q8h,Day1-Day7
EXPERIMENTAL: 0.24mg/kg,KB
Group C:0.24mg/kg,Q8h,Day1-Day7
Drug: 0.24mg/,KB
0.24mg/kg,Q8h,Day1-Day7
EXPERIMENTAL: Placebos
Group D:Placebos,Q8h,Day1-Day7
Drug: Placebos
Placebos,Q8h,Day1-Day7

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Day-1 to Day8
AE, physical examination, monitoring of vital signs, Laboratory examination etc.
Day-1 to Day8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Chasesun Pharmaceutical Co., LTD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Southwest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HR-KB104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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