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

NCT01311518 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-09-22

No results posted yet for this 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.

Conditions

  • Acute Myocardial Infarction
  • ST Elevation Myocardial Infarction
  • STEMI

Interventions

DRUG

Drug: Placebo

Injectable administration by slow intravenous bolus, 0.00% Thymosin Beta 4 daily for 3 days then weekly for 4 consecutive weeks

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

Sponsors & Collaborators

  • RegeneRx Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • J.J. Finkelstein, BBA · RegeneRx Biopharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01311518 on ClinicalTrials.gov