AzTrials
AzTrials

Acute Myocardial InfarctionPhase 2NCT05485818

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

A Phase 2 study testing Low Dose, Middle Dose and High Dose in people with Acute Myocardial Infarction, run by Beijing Northland Biotech. Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Low Dose, Middle Dose and High Dose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteChina
Study dates
23 Nov 2020to 18 Nov 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing

Other trials in China

About this study

Official title: Phase IIa Clinical Study of Efficacy and Safety of Injectable Recombinant Human Thymosin Beta 4 in Patients With Acute Myocardial Infarction

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.

Being tested
Low Dose, Middle Dose, High Dose, Placebo
Keywords
AMI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low DoseDrug

    Also called NL005（ 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）

  • Middle DoseDrug

    Also called NL005（ 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）

  • High DoseDrug

    Also called NL005（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）

  • PlaceboOther

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

Study groups in NCT05485818
Study groupRoleWhat they receive
Low DoseExperimentalPatients in this treatment group will receive NL005 for 0.25 ug/kg respective.Continuous administration for 7 days.
Receives: Drug: Low Dose
Middle DoseExperimentalPatients in this treatment group will receive NL005 for 0.5 ug/kg respective.Continuous administration for 7 days.
Receives: Drug: Middle Dose
High DoseExperimentalPatients in this treatment group will receive NL005 for 2.0 ug/kg respective.Continuous administration for 7 days.
Receives: Drug: High Dose
PlaceboPlacebo comparatorPatients in this treatment group will receive placebo respective. Continuous administration for 7 days.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 5、Day 90

Secondary outcomes (9)

  1. 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.

    Measured: Day 5、Day 90

  2. 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.

    Measured: Day 5、Day 90

  3. 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.

    Measured: Day 5、Day 90

  4. 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.

    Measured: Day 5、Day 90

  5. 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.

    Measured: Day 5、Day 90

  6. 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.

    Measured: Day 5、Day 90

  7. 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.

    Measured: Day 5、Day 90

  8. 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

    Measured: Day0、Day1、Day2、Day3、Day4、Day5、Day6、Day7、Day30、Day90

  9. Incidence of anti-drug antibody (ADA)

    Blood samples were collected before administration and 30 days after PCI to evaluate the immunogenicity of NL005

    Measured: Day 0、Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start23 Nov 2020
  3. Primary completion30 Sep 2021
  4. Study completion18 Nov 2021

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485818
Sponsor's protocol ID
NL005-AMI-IIa
Status last verified
Aug 2022
First submitted
7 Sep 2020
Last updated
3 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low Dose, Middle Dose and High Dose in people with Acute Myocardial Infarction, run by Beijing Northland Biotech. 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 13 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 3 Aug 2022. 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?

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?

Change of myocardial infarction area on Day 5 and day 90 after PCI (time frame: Day 5、Day 90). 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 NCT05485818, which also lists 6 linked publications.

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 3 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in