Clinical trial NCT01311518: A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Myocardial Infarction
ST Elevation Myocardial Infarction
STEMI
Keywords: Thymosin Beta 4
Thymosin β4 (Tβ4) Injectable Solution
RGN-352
Lead sponsor: RegeneRx Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total MRI infarct zone derived from cardiac MRI scan
timeFrame: Day 28
Secondary outcomes:
measure: MRI-derived myocardial salvage index, mass, Left Ventricle (LV) ejection fraction,systolic and end diastolic volumes
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
affiliation: RegeneRx Biopharmaceuticals, Inc.
name: J.J. Finkelstein, BBA
role: STUDY_DIRECTOR
References: