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

Last updated: September 15, 2021
Sponsor: RegeneRx Biopharmaceuticals, Inc.
Overall Status: Trial Not Available

Phase

2

Condition

Blood Clots

Angina

Myocardial Ischemia

Treatment

N/A

Clinical Study ID

NCT01311518
RGN-MI-201
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 authorizedrepresentatives

Exclusion

Exclusion Criteria:

  1. Intention to treat subject with thrombolytic therapy following assertion ofThrombolysis 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 fillingpressure or requiring catecholamines) or other hemodynamic instability at baseline
  5. Further transcatheter or surgical revascularization, e.g., coronary artery bypassgraft 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 surgicallysterilized (bilateral tubal ligation or hysterectomy), do not have a partner withdocumented sterility (including vasectomy), or are not using adequate contraception (combined hormonal or double-barrier method of contraception, or sexual abstinence arethe 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 orother comorbid disease, except current cardiovascular disease

Study Design

Study Start date:
July 01, 2019
Estimated Completion Date:
July 31, 2020

Study 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.

Connect with a study center

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • The Valley Hospital

    Ridgewood, New Jersey 07450
    United States

    Site Not Available

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