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

What Was Tested

This registered phase 2 trial tested TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).

It had two arms (groups): Placebo (placebo comparator) and Drug: Thymosin Beta 4 injectable (active comparator).

The registry classes the interventions as drug.

More on the Plan

Approximately 75 subjects will be randomized to study treatment to achieve at least 60 evaluable subjects with 20 to 25 subjects per group.

Study subjects will undergo cardiac angiography to assess initial coronary artery patency and Thrombolysis In Myocardial Infarction flow grade both pre- and post-percutaneous coronary intervention (PCI) angioplasty.

Follow-up is on Months 2, 4, and 6.

Who Took Part

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female subjects. Negative urine pregnancy test at Screening. First acute anterior MI. Onset of chest pain symptoms to initial PCI angioplasty time is 2 to 6 hours. Written informed consent reviewed and signed by the subject or legally authorized representatives.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: intention to treat subject with thrombolytic therapy following assertion of thrombolysis in myocardial infarction(timi) flow 0 or 1 during qualifying angiogram; history of myocardial infarctioni or congestive heart failure; non-atherosclerotic etiology of acute myocardial infarction.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the TB-500 (Thymosin Beta-4 fragment) group and the comparison group should start out alike.

The TB-500 (Thymosin Beta-4 fragment) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received TB-500 (Thymosin Beta-4 fragment).

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-07 with completion listed for 2020-07.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Total MRI infarct zone derived from cardiac MRI scan (time frame: Day 28).

It also tracked 1 secondary outcome, for example MRI-derived myocardial salvage index, mass, Left Ventricle (LV) ejection fraction,systolic and end diastolic volumes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the TB-500 (Thymosin Beta-4 fragment) compound page and the Thymosin Beta-4 (full length) compound page, all human trials.