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

NCT01311518 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: RGN-MI-201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Thymosin Beta 4; Thymosin β4 (Tβ4) Injectable Solution; RGN-352

Outcome Measures

Primary Outcomes (1)

• Total MRI infarct zone derived from cardiac MRI scan

  Day 28

Secondary Outcomes (1)

• MRI-derived myocardial salvage index, mass, Left Ventricle (LV) ejection fraction,systolic and end diastolic volumes

  Day 28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Drug: Placebo

Drug: Thymosin Beta 4 injectable

ACTIVE COMPARATOR

Drug: Drug: Injectable Thymosin beta 4

Interventions

Drug: Placebo DRUG

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

Also known as: 0.00% Thymosin Beta 4

Placebo

Drug: Injectable Thymosin beta 4 DRUG

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

Also known as: Injectable Thymosin Beta 4, Tβ4 Injectable Solution, RGN-352

Drug: Thymosin Beta 4 injectable

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects
• Negative urine pregnancy test at Screening
• An electrocardiogram
• First acute anterior MI
• Baseline angiography
• 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

You may not qualify if:

• 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
• Cardiogenic shock (systolic blood pressure \<90 despite adequate left ventricle filling pressure or requiring catecholamines) or other hemodynamic instability at baseline
• Further transcatheter or surgical revascularization, e.g., coronary artery bypass graft planned per baseline angiogram
• Lactating women
• Past or present evidence of malignancy
• 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)
• Ongoing infectious disease including human immunodeficiency virus (HIV) and hepatitis
• Clinically significant respiratory, renal, metabolic, liver, central nervous system or other comorbid disease, except current cardiovascular disease

Sponsors & Collaborators

• RegeneRx Biopharmaceuticals, Inc.: lead

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

thymosin beta(4)

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• J.J. Finkelstein, BBA

  RegeneRx Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 9, 2011
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 22, 2021

Record last verified: 2021-09