SepsisPhase 2NCT04803955
Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients
A Phase 2 study testing 16mg，KB in people with Sepsis, run by Tianjin Chasesun Pharmaceutical Co., LTD at 1 site in China.
Trial summary
Phase II study of Kukoamine B Mesilate in Sepsis Patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis
- What is being tested?
- 16mg，KB
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2021to 30 Jun 2024
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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;
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- (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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Shuai Chen, Bachelor, 18600050139, 18600050139@126.com
About this study
Official title: Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients: a Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Trial
Phase II study of Kukoamine B Mesilate in Sepsis Patients
Read the detailed description
To Assess Efficacy,Safety,Pharmacokinetics of Kukoamine B Mesilate in Sepsis Patients
- Conditions
- Sepsis
- Being tested
- 16mg，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.
16mg，KBDrug
16mg,Q8h±3min,Day1-Day7
PlacebosDrug
16mg,Q8h±3min,Day1-Day7
| Study group | Role | What they receive |
|---|---|---|
| 16mg,KB | Experimental | Group A:16mg,Q8h±3min,Day1-Day7 Receives: Drug: 16mg，KB |
| Placebos | Placebo comparator | Group B:Placebos,Q8h±3min,Day1-Day7 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta SOFA (ΔSOFA)
Change in SOFA scale from baseline.
Measured: Day 8 after the first dose (Within 24 hours after the last dose on day 7)
Secondary outcomes (8)
Clinical Outcome Composite Endpoint
Proportion of patients with 28-day all-cause deaths and continuing ICU stay after the first dose.
Measured: 28 days after the first dose
Proportion of patients with 7-day all-cause deaths
Proportion of patients with 7-day all-cause deaths after first dose.
Measured: 7 days after the first dose
Proportion of patients transferred out of ICU
Proportion of patients transferred out of ICU within 7 days after first dose.
Measured: 7 days after the first dose
Quantification of IL-6
Change of IL-6 from baseline on day 2,4,8 after first dose (Within 24 hours after the last dose on day 7).
Measured: Day 2, 4 , 8 after the first dose (Within 24 hours after the last dose on day 7)
Delta SOFA (ΔSOFA)
Change in SOFA scale from baseline on day 1,3 ,5 after first dose.
Measured: Day 1, 3, 5 after the first dose
Duration of use and abstention of life support treatment
Duration of use and abstention of life support treatment (vasoactive drugs, mechanical ventilation, CRRT) .
Measured: 28 days after the first dose
Duration of ICU stay and absence
Duration of ICU stay and absence within 28 days after the first dose.
Measured: 28 days after the first dose
Rate of adverse events/serious adverse events
Observe all the participants in any adverse events occurred during the period of clinical research, including clinical symptoms and signs of life, an abnormal in laboratory tests, record its clinical characteristics, severity, occurrence time, duration, treatment and prognosis, and determine its and the correlation between test drugs. CTCAE v5.0 standard was used to evaluate drug safety.
Measured: From date of singing informed consent until the 29 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start15 May 2021
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 424 participants (estimated)
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
- NCT04803955
- Sponsor's protocol ID
- HR-KB201
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Kukoamine B Mesilate in Sepsis Patients: a Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04803955
- Acronym / sponsor ID
- HR-KB201
- Conditions
- Sepsis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- Tianjin Chasesun Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Southwest Hospital, China
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Mar 2021 (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 II study of Kukoamine B Mesilate in Sepsis Patients
Detailed description
To Assess Efficacy,Safety,Pharmacokinetics of 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
- 2
| Arm | Type | Receives |
|---|---|---|
| 16mg,KB | Experimental | Drug: 16mg，KBGroup A:16mg,Q8h±3min,Day1-Day7 |
| Placebos | Placebo comparator | Drug: PlacebosGroup B:Placebos,Q8h±3min,Day1-Day7 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (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;
Key exclusion criteria (18 listed)
- (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;
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 |
|---|---|---|
| 16mg，KB16mg,Q8h±3min,Day1-Day7 | Drug | 16mg,KB |
| Placebos16mg,Q8h±3min,Day1-Day7 | Drug | Placebos |
Primary outcome
Delta SOFA (ΔSOFA)
Time frame: Day 8 after the first dose (Within 24 hours after the last dose on day 7)
Change in SOFA scale from baseline.
8 secondary outcomes
Clinical Outcome Composite Endpoint
Time frame: 28 days after the first dose
Proportion of patients with 7-day all-cause deaths
Time frame: 7 days after the first dose
Proportion of patients transferred out of ICU
Time frame: 7 days after the first dose
Quantification of IL-6
Time frame: Day 2, 4 , 8 after the first dose (Within 24 hours after the last dose on day 7)
Delta SOFA (ΔSOFA)
Time frame: Day 1, 3, 5 after the first dose
Duration of use and abstention of life support treatment
Time frame: 28 days after the first dose
Duration of ICU stay and absence
Time frame: 28 days after the first dose
Rate of adverse events/serious adverse events
Time frame: From date of singing informed consent until the 29 days after the first dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 16mg，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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuai Chen, Bachelor (+86 022-59623160, 18600050139@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta SOFA (ΔSOFA) (time frame: Day 8 after the first dose (Within 24 hours after the last dose on day 7)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2024.