CompletedNCT05485818Updated Aug 3, 2022

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

A Phase 2 interventional study of Low Dose and Middle Dose in Acute Myocardial Infarction, sponsored by Beijing Northland Biotech. Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by Beijing Northland Biotech. Co., Ltd. · Phase 2, Interventional, and Basic science

Phase: Phase 2
Study type: Interventional
Enrollment: 62
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Acute Myocardial Infarction

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In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 62 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

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Lead sponsor

Beijing Northland Biotech. Co., Ltd. is the lead sponsor of 11 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

The subject or its legal representative will voluntarily participate in the study and sign the informed consent;
Age 18 and 75, regardless of gender;
STEMI patients with left anterior descending branch single-artery middle occlusion (TIMI grading 0\~1, see Appendix 1 for TIMI grading) and receiving PCI;
No obvious collateral of coronary artery (Rentrop grade 0\~1,Rentrop grade see Appendix 2);
Chest pain occurred for 6 hours and 12 hours before PCI;
TIMI grade 3 after PCI;
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

Exclusion Criteria:

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

Study design

Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 62 participants (actual)

Study arms

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
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
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
Placebo comparator
Placebo
Patients in this treatment group will receive placebo respective. Continuous administration for 7 days.
Other: Placebo

Interventions

DrugLow 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）
Also known as: NL005（ Low Dose）
DrugMiddle 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）
Also known as: NL005（ Middle Dose）
DrugHigh 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）
Also known as: NL005（High Dose）
OtherPlacebo
15 subjects will be randomly assigned to the placebo for 7 days

What researchers measure

Primary outcomes

Change of myocardial infarction area on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90

Secondary outcomes

Change of myocardial salvage index on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90
Change of microvascular obstruction area on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90
Change of LA on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90
Changeof LV on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90
Change of LVEF on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90
Change of LVESV on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90
Change of LVEDV on Day 5 and day 90 after PCI
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.
Time frame: Day 5、Day 90
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Number of participants with adverse events (AE), treatment-related adverse events, abnormal vital signs, abnormal physical examination findings, abnormal laboratory test results, abnormal electrocardiograms
Time frame: Day0、Day1、Day2、Day3、Day4、Day5、Day6、Day7、Day30、Day90
Incidence of anti-drug antibody (ADA)
Blood samples were collected before administration and 30 days after PCI to evaluate the immunogenicity of NL005
Time frame: Day 0、Day 30

Study locations

1 site

Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China

References and documents

Publications

Limana F, Capogrossi MC, Germani A. The epicardium in cardiac repair: from the stem cell view. Pharmacol Ther. 2011 Jan;129(1):82-96. doi: 10.1016/j.pharmthera.2010.09.002. Epub 2010 Oct 19. PubMed 20937304 ↗
Wrigley BJ, Lip GY, Shantsila E. The role of monocytes and inflammation in the pathophysiology of heart failure. Eur J Heart Fail. 2011 Nov;13(11):1161-71. doi: 10.1093/eurjhf/hfr122. Epub 2011 Sep 27. PubMed 21952932 ↗
Gutierrez SH, Kuri MR, del Castillo ER. Cardiac role of the transcription factor NF-kappaB. Cardiovasc Hematol Disord Drug Targets. 2008 Jun;8(2):153-60. doi: 10.2174/187152908784533702. PubMed 18537603 ↗
Gordon JW, Shaw JA, Kirshenbaum LA. Multiple facets of NF-kappaB in the heart: to be or not to NF-kappaB. Circ Res. 2011 Apr 29;108(9):1122-32. doi: 10.1161/CIRCRESAHA.110.226928. PubMed 21527742 ↗
Srivastava D, Ieda M, Fu J, Qian L. Cardiac repair with thymosin beta4 and cardiac reprogramming factors. Ann N Y Acad Sci. 2012 Oct;1270:66-72. doi: 10.1111/j.1749-6632.2012.06696.x. PubMed 23050819 ↗
Dube KN, Bollini S, Smart N, Riley PR. Thymosin beta4 protein therapy for cardiac repair. Curr Pharm Des. 2012;18(6):799-806. doi: 10.2174/138161212799277699. PubMed 22236126 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05485818
Lead sponsor: Beijing Northland Biotech. Co., Ltd.
Responsible party: Sponsor
First posted: Aug 3, 2022
Start date: Nov 23, 2020
Primary completion: Sep 30, 2021
Completion: Nov 18, 2021
Last update: Aug 3, 2022

Study contacts

KeFei Dou

principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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