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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-23

Study Completion Date

2021-11-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05984134

Acute Myocardial Infarction

COMPLETED PHASE2

A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers

NCT00743769

Myocardial Infarction Myocardial Ischemia

WITHDRAWN PHASE1

A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction

NCT01311518

Acute Myocardial Infarction ST Elevation Myocardial Infarction STEMI

WITHDRAWN PHASE2

Intracoronary rhTNK-tPA Versus Tirofiban in Patients With STEMI and High Thrombus Burden

NCT06769256

ST-segment Elevation Myocardial Infarction (STEMI)

RECRUITING PHASE4

Thrombolysis in Myocardial Infarction (TIMI)

NCT00000505

Cardiovascular Diseases Coronary Disease Heart Diseases +2 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low Dose

Patients in this treatment group will receive NL005 for 0.25 ug/kg respective.Continuous administration for 7 days.

Group Type EXPERIMENTAL

Low Dose

Intervention Type DRUG

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）

Middle Dose

Patients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days.

Group Type EXPERIMENTAL

Middle Dose

Intervention Type DRUG

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）

High Dose

Patients in this treatment group will receive NL005 for 2.0 ug/kg respective.Continuous administration for 7 days.

Group Type EXPERIMENTAL

High Dose

Intervention Type DRUG

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）

Placebo

Patients in this treatment group will receive placebo respective. Continuous administration for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

15 subjects will be randomly assigned to the placebo for 7 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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）

Intervention Type 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）

Intervention Type 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）

Intervention Type DRUG

Placebo

15 subjects will be randomly assigned to the placebo for 7 days

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NL005（ Low Dose） NL005（ Middle Dose） NL005（High Dose）

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No