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

This study has suspended participant recruitment.

(Trial suspended due to drug product manufacturer not GMP compliant)

Sponsor:

Information provided by (Responsible Party):

RegeneRx Biopharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01311518

First received: March 7, 2011

Last updated: November 16, 2012

Last verified: November 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction ST Elevation Myocardial Infarction STEMI	Drug: Drug: Placebo Drug: Drug: Injectable Thymosin beta 4	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by RegeneRx Biopharmaceuticals, Inc.:

Primary Outcome Measures:

Total MRI infarct zone derived from cardiac MRI scan [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MRI-derived myocardial salvage index, mass, Left Ventricle (LV) ejection fraction,systolic and end diastolic volumes [ Time Frame: Day 28 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	March 2013
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311518

Locations

United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, New Jersey
The Valley Hospital
Ridgewood, New Jersey, United States, 07450

Sponsors and Collaborators

RegeneRx Biopharmaceuticals, Inc.

Investigators

Study Director:	John Strobeck, MD	The Valley Hospital , Ridegewood, NJ 07450
Study Director:	Zachary Hodes, MD	St Vincent Indianapolis Hospital

More Information

No publications provided

Responsible Party:	RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01311518 History of Changes
Other Study ID Numbers:	RGN-MI-201
Study First Received:	March 7, 2011
Last Updated:	November 16, 2012
Health Authority:	United States: Food and Drug Administration Israel: Ministry of Health Russia: Ministry of Health of the Russian Federation

Keywords provided by RegeneRx Biopharmaceuticals, Inc.:

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

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis

Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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