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

September 15, 2021 updated by: RegeneRx Biopharmaceuticals, Inc.

A Randomized, Double-blind, Placebo-Controlled, Study of the Safety and Efficacy of RGN-352 in Subjects With an Acute ST Elevation Myocardial Infarction (STEMI) After Occlusion of the Proximal Left Anterior Descending Coronary Artery

The objective of this study is to evaluate the safety and tolerability of two active doses of RGN-352 (thymosin beta 4, Tβ4, Injectable Solution) in patients with acute myocardial infarction receiving percutaneous coronary intervention angioplasty with or without stent placement. Approximately 75 subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 more weeks.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, placebo controlled, parallel-group, dose finding study. Eligible subjects will be randomized to receive one of two doses of RGN-352 or matching placebo with an equal allocation ratio (i.e., 1:1:1). Approximately 75 subjects will be randomized to study treatment to achieve at least 60 evaluable subjects with 20 to 25 subjects per group. Subjects will be randomized to receive one of two RGN-352 doses of 1200 mg, or 450 mg, or placebo, administered iv by iv push daily for the first 3 consecutive days and weekly for 4 consecutive weeks. 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. A total of 7 doses will be administrated over the treatment period. The first dose of either RGN-352 or placebo will be administered to randomized subjects following PCI angioplasty and specifically within 30 minutes after balloon deflation, with a further 2 doses. The remaining 4 doses will be given weekly for 4 consecutive weeks. Follow-up is on Months 2, 4, and 6.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects
  2. Negative urine pregnancy test at Screening
  3. An electrocardiogram
  4. First acute anterior MI
  5. Baseline angiography
  6. Onset of chest pain symptoms to initial PCI angioplasty time is 2 to 6 hours
  7. Written informed consent reviewed and signed by the subject or legally authorized representatives

Exclusion Criteria:

  1. Intention to treat subject with thrombolytic therapy following assertion of Thrombolysis In Myocardial Infarction(TIMI) flow 0 or 1 during qualifying angiogram
  2. History of Myocardial infarctionI or congestive heart failure
  3. Non-atherosclerotic etiology of acute myocardial infarction
  4. Cardiogenic shock (systolic blood pressure <90 despite adequate left ventricle filling pressure or requiring catecholamines) or other hemodynamic instability at baseline
  5. Further transcatheter or surgical revascularization, e.g., coronary artery bypass graft planned per baseline angiogram
  6. Lactating women
  7. Past or present evidence of malignancy
  8. Women who have had menarche but have not completed menopause, have not been surgically sterilized (bilateral tubal ligation or hysterectomy), do not have a partner with documented sterility (including vasectomy), or are not using adequate contraception (combined hormonal or double-barrier method of contraception, or sexual abstinence are the only methods of contraception acceptable for this study)
  9. Ongoing infectious disease including human immunodeficiency virus (HIV) and hepatitis
  10. Clinically significant respiratory, renal, metabolic, liver, central nervous system or other comorbid disease, except current cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Drug: Placebo
Injectable administration by slow intravenous bolus, 0.00% Thymosin Beta 4 daily for 3 days then weekly for 4 consecutive weeks
Other Names:
  • 0.00% Thymosin Beta 4
Active Comparator: Drug: Thymosin Beta 4 injectable
Drug: Drug: Injectable Thymosin beta 4
Injectable administration of Thymosin Beta 4 by intravenous bolus at 1200 mg, or 450 mg daily for 3 days then weekly for 4 consecutive weeks
Other Names:
  • Injectable Thymosin Beta 4
  • Tβ4 Injectable Solution
  • RGN-352

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total MRI infarct zone derived from cardiac MRI scan
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
MRI-derived myocardial salvage index, mass, Left Ventricle (LV) ejection fraction,systolic and end diastolic volumes
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RegeneRx Biopharmaceuticals, Inc.

Investigators

  • Study Director: J.J. Finkelstein, BBA, RegeneRx Biopharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 9, 2011

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGN-MI-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST Elevation Myocardial Infarction

Clinical Trials on Drug: Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe