SepsisPhase 1NCT03237728
Study of Multiple-dose Kukoamine B Mesilate in Sepsis Patients
A Phase 1 study testing 0.06mg/kg,KB, 0.12mg/kg,KB and 0.24mg/,KB in people with Sepsis, run by Tianjin Chasesun Pharmaceutical Co., LTD at 1 site in China.
Trial summary
Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sepsis
- What is being tested?
- 0.06mg/kg,KB, 0.12mg/kg,KB and 0.24mg/,KB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2017to 25 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Participated in clinical intervention test in 3 months;
- The subject is a researcher or his immediate family member, or may have improper informed consent;
- The attending physician considers it inappropriate for the patient to participate in this test.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: 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
Read the detailed description
To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B Mesilate in Sepsis Patients
- Conditions
- Sepsis
- Being tested
- 0.06mg/kg,KB, 0.12mg/kg,KB, 0.24mg/,KB, Placebos
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.06mg/kg,KBDrug
0.06mg/kg,Q8h,Day1-Day7
0.12mg/kg,KBDrug
0.12mg/kg,Q8h,Day1-Day7
0.24mg/,KBDrug
0.24mg/kg,Q8h,Day1-Day7
PlacebosDrug
Placebos,Q8h,Day1-Day7
| Study group | Role | What they receive |
|---|---|---|
| 0.06mg/kg,KB and Placebo | Experimental | Group A:0.06mg/kg,Q8h,Day1-Day7 Receives: Drug: 0.06mg/kg,KB; Drug: Placebos |
| 0.12mg/kg,KB | Experimental | Group B:0.12mg/kg,Q8h,Day1-Day7 Receives: Drug: 0.12mg/kg,KB |
| 0.24mg/kg,KB | Experimental | Group C:0.24mg/kg,Q8h,Day1-Day7 Receives: Drug: 0.24mg/,KB |
| Placebos | Experimental | Group D:Placebos,Q8h,Day1-Day7 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
AE, physical examination, monitoring of vital signs, Laboratory examination etc.
Measured: Day-1 to Day8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start28 Jul 2017
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Chasesun Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southwest Hospital, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237728
- Sponsor's protocol ID
- HR-KB104
- Status last verified
- Apr 2019
- First submitted
- 31 Jul 2017
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37116228
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind Placebo-controlled Clinical Study to Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of Multiple-dose Kukoamine B Mesilate in Sepsis Patients
- ClinicalTrials.gov ID
- NCT03237728
- Acronym / sponsor ID
- HR-KB104
- Conditions
- Sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tianjin Chasesun Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Southwest Hospital, China
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I study of multiple-dose Kukoamine B Mesilate in Sepsis Patients
Detailed description
To Assess Safety, Tolerance, Pharmacokinetics, Pharmacodynamic of multiple-dose Kukoamine B Mesilate in Sepsis Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.06mg/kg,KB and Placebo | Experimental | Drug: 0.06mg/kg,KB, Drug: PlacebosGroup A:0.06mg/kg,Q8h,Day1-Day7 |
| 0.12mg/kg,KB | Experimental | Drug: 0.12mg/kg,KBGroup B:0.12mg/kg,Q8h,Day1-Day7 |
| 0.24mg/kg,KB | Experimental | Drug: 0.24mg/,KBGroup C:0.24mg/kg,Q8h,Day1-Day7 |
| Placebos | Experimental | Drug: PlacebosGroup D:Placebos,Q8h,Day1-Day7 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.06mg/kg,KB0.06mg/kg,Q8h,Day1-Day7 | Drug | 0.06mg/kg,KB and Placebo |
| 0.12mg/kg,KB0.12mg/kg,Q8h,Day1-Day7 | Drug | 0.12mg/kg,KB |
| 0.24mg/,KB0.24mg/kg,Q8h,Day1-Day7 | Drug | 0.24mg/kg,KB |
| PlacebosPlacebos,Q8h,Day1-Day7 | Drug | 0.06mg/kg,KB and Placebo, Placebos |
Primary outcome
Incidence of adverse events
Time frame: Day-1 to Day8
AE, physical examination, monitoring of vital signs, Laboratory examination etc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 37116228Hu 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.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.06mg/kg,KB, 0.12mg/kg,KB and 0.24mg/,KB in people with Sepsis, run by Tianjin Chasesun Pharmaceutical Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Day-1 to Day8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03237728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.