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

NCT ID: NCT01311518

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-07-31

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.

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.

Conditions

Acute Myocardial Infarction; ST Elevation Myocardial Infarction; STEMI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Drug: Placebo

Intervention Type: DRUG

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

Drug: Thymosin Beta 4 injectable

Group Type: ACTIVE_COMPARATOR

Drug: Injectable Thymosin beta 4

Intervention Type: 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

Interventions

Drug: Placebo

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

0.00% Thymosin Beta 4; Injectable Thymosin Beta 4; Tβ4 Injectable Solution; RGN-352

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RegeneRx Biopharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J.J. Finkelstein, BBA

Role: STUDY_DIRECTOR

RegeneRx Biopharmaceuticals, Inc.

Other Identifiers

RGN-MI-201

Identifier Type: -

Identifier Source: org_study_id