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Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05485818
Recruitment Status : Completed
First Posted : August 3, 2022
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
Beijing Northland Biotech. Co., Ltd.

Brief Summary:
A multicenter randomized double-blind placebo parallel control design was used in this study.60 subjects eligible for inclusion will be randomly assigned to either a low-dose (0.25ug/kg) medium-dose (0.5ug/kg) high-dose (2.0ug/kg) experimental drug group or a control group (placebo) at a ratio of 1:1:1:1.After randomization, subjects received the experimental drug or placebo once a day, intravenously, on day 2 to 7, 12 hours and 4 hours after PCI.Ninety days after PCI were observed.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Low Dose Drug: Middle Dose Drug: High Dose Other: Placebo Phase 2

Detailed Description:

Subjects underwent cardiovascular magnetic resonance imaging (CMR) on the 90th day after PCI, which was used to evaluate the myocardial salvage index myocardial infarction area, microvascular occlusion area, left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), and left ventricular end-diastolic volume (LVEDV).Echocardiography was performed on the 5th and the 90th day after PCI to evaluate the left indoor diameter (LV) and left atrial diameter (LA) of LVEF.

Physical examination routine blood coagulation function was performed on the 30th and 90th day after PCI in the screening period (pre-screening results were acceptable);Electrocardiogram (ECG) was performed on the 30th and the 90th day after PCI on the 2nd day after the first administration;During the screening period (results before screening are acceptable), vital signs should be measured from day 1 to day 7 after PCI (during each dose, vital signs should be measured twice on day 7, including before and after administration), on day 30 and day 90;Blood biochemical examinations were performed from day 2 to day 4, day 7, day 30, and day 90 after PCI before the first administration;Creatine kinase isoenzyme (CK-MB) hypersensitive troponin I(HS-CTNI) or troponin I(cTnI) and amino-terminal B-type natriuretic peptide precursor (NT-probNP) or B-type natriuretic peptide (BNP) were detected on day 2, day 3, day 4 and day 7 after PCI before the first administration.Tumor markers were detected and immunogenicity blood samples were collected 30 days after PCI before the first administration.Routine urinalysis was performed 90 days after PCI before the first administration;Adverse drug events and cardiovascular events were continuously recorded during the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Phase IIa Clinical Study of Efficacy and Safety of Injectable Recombinant Human Thymosin Beta 4 in Patients With Acute Myocardial Infarction
Actual Study Start Date : November 23, 2020
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : November 18, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Low Dose
Patients in this treatment group will receive NL005 for 0.25 ug/kg respective.Continuous administration for 7 days.
Drug: Low Dose
12±4 hours after PCI: 0.25 ug/kg Recombinant Human Thymosin β4 (intravenous injection),Day2-Day7 after PCI:0.25 ug/kg Recombinant Human Thymosin β4 (intravenous injection)
Other Name: NL005( Low Dose)

Experimental: Middle Dose
Patients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days.
Drug: Middle Dose
12±4 hours after PCI: 0.5 ug/kg Recombinant Human Thymosin β4 (intravenous injection),Day2-Day7 after PCI:0.5 ug/kg Recombinant Human Thymosin β4 (intravenous injection)
Other Name: NL005( Middle Dose)

Experimental: High Dose
Patients in this treatment group will receive NL005 for 2.0 ug/kg respective.Continuous administration for 7 days.
Drug: High Dose
12±4 hours after PCI: 2.0 ug/kg Recombinant Human Thymosin β4 (intravenous injection),Day2-Day7 after PCI:2.0 ug/kg Recombinant Human Thymosin β4 (intravenous injection)
Other Name: NL005(High Dose)

Placebo Comparator: Placebo
Patients in this treatment group will receive placebo respective. Continuous administration for 7 days.
Other: Placebo
15 subjects will be randomly assigned to the placebo for 7 days




Primary Outcome Measures :
  1. Change of myocardial infarction area on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Change of myocardial infarction area on Day 5 and day 90 after PCI. Myocardial infarction area day 5 and day 90 after PCI,and the change on day 90 compared to day 5. Myocardial infarction size was evaluated by late gadolinium enhanced cardiac magnetic resonance (LGE-CMR) imaging.


Secondary Outcome Measures :
  1. Change of myocardial salvage index on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Myocardial salvage index day 5 and day 90 after PCI,and the change on day 90 compared to day 5. Myocardial salvage index (%) defifined as: (area at risk-infarct size)/ area at risk*100% measured by CMR. Higher scores mean a better outcome.

  2. Change of microvascular obstruction area on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Area of microvascular obstruction day 5 and day 90 after PCI,and the change on day 90 compared to day 5. Microvascular obstruction is one of the risk factors affecting the prognosis of AMI patients. The occurrence of MVO is related to the release of cytotoxic factors caused by distal microvascular embolization and reperfusion injury. Studies have shown a significantly increased risk of heart failure, adverse cardiovascular events, and death. late gadolinium enhancement (LGE) was performed to identify areas of microvascular obstruction (MVO), the typical MVO is the low signal area in the high signal area of infarction.

  3. Change of LA on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Change of left atrium (LA) on Day 5 and day 90 after PCI, The data of LA after PCI were measured by CMR at Day 5 and day 90, and calculate changes in data day 90 and day 5.

  4. Changeof LV on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Change of left ventricle (LV) on Day 5 and day 90 after PCI, Day 5 and day 90 LV after PCIwere measured by CMR at Day 5 and day 90, and calculate changes in data day 90 and day 5.

  5. Change of LVEF on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Change of Left Ventricular Ejection Fractions (LVEF) on Day 5 and day 90 after PCI, Day 5 and day 90 LVEF after PCIwere measured by CMR at Day 5 and day 90, and calculate changes in data day 90 and day 5.

  6. Change of LVESV on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Change of Left Ventricular end-systolic volume (LVESV) on Day 5 and day 90 after PCI, Day 5 and day 90 LVESV after PCI were measured by CMR at Day 5 and day 90, and calculate changes in data day 90 and day 5.

  7. Change of LVEDV on Day 5 and day 90 after PCI [ Time Frame: Day 5、Day 90 ]
    Change of Left Ventricular end-diastolic volume (LVEDV) on Day 5 and day 90 after PCI, Day 5 and day 90 LVEDV after PCI were measured by CMR at Day 5 and day 90, and calculate changes in data day 90 and day 5.

  8. Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0 [ Time Frame: Day0、Day1、Day2、Day3、Day4、Day5、Day6、Day7、Day30、Day90 ]
    Number of participants with adverse events (AE), treatment-related adverse events, abnormal vital signs, abnormal physical examination findings, abnormal laboratory test results, abnormal electrocardiograms

  9. Incidence of anti-drug antibody (ADA) [ Time Frame: Day 0、Day 30 ]
    Blood samples were collected before administration and 30 days after PCI to evaluate the immunogenicity of NL005



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject or its legal representative will voluntarily participate in the study and sign the informed consent;
  2. Age 18 and 75, regardless of gender;
  3. STEMI patients with left anterior descending branch single-artery middle occlusion (TIMI grading 0~1, see Appendix 1 for TIMI grading) and receiving PCI;
  4. No obvious collateral of coronary artery (Rentrop grade 0~1,Rentrop grade see Appendix 2);
  5. Chest pain occurred for 6 hours and 12 hours before PCI;
  6. TIMI grade 3 after PCI;
  7. All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier contraceptive methods, abstinence) during the study period and up to 6 months after the last administration, and women of childbearing age must test negative for pregnancy before administration.

Exclusion Criteria:

  1. Patients who have a history of myocardial infarction or have received coronary artery acute thrombolytic interventional therapy with bypass surgery;
  2. patients who received thrombolytic therapy after onset;
  3. patients who were clearly diagnosed as acute heart failure (Killip grade II,Killip classification in annex 3);
  4. Severe arrhythmia that cannot be corrected;
  5. Aortic dissection or suspected presence;
  6. Severe liver and kidney dysfunction or severe depletion, etc;
  7. major surgical history or hemorrhagic stroke in half a year;
  8. Has or has a history of malignancy;
  9. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg in patients with hypertension after active antihypertensive treatment;
  10. Clinically, he had a significant history of allergy, especially to mannitol, drugs, protein preparations and biological products;
  11. Screening of patients who participated in other clinical studies within the first 3 months;
  12. Failure to perform CMR test: such as claustrophobia, renal failure (eGFR < 30ml/min);
  13. Other conditions not considered suitable for inclusion by the researcher.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05485818


Locations
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China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Sponsors and Collaborators
Beijing Northland Biotech. Co., Ltd.
Investigators
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Principal Investigator: KeFei Dou Chinese Academy of Medical Sciences, Fuwai Hospital
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Beijing Northland Biotech. Co., Ltd.
ClinicalTrials.gov Identifier: NCT05485818    
Other Study ID Numbers: NL005-AMI-IIa
First Posted: August 3, 2022    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Northland Biotech. Co., Ltd.:
AMI
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases