Current partner codePEPTIDESDE
NCT01311518·Phase 2·INTERVENTIONAL

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

Status

Withdrawn

Phase

Phase 2

Enrollment

0

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Mar 9, 2011

  2. Study start

    Jul 2019

  3. Primary completion

    Jul 2020

  4. Study completion

    Jul 2020

  5. Results posted

    Not reported

  6. Registry updated

    Sep 22, 2021

Outcomes

What the study measures.

Primary outcomes

Total MRI infarct zone derived from cardiac MRI scan

Time frame · Day 28

Secondary outcomes

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

Time frame · Day 28

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Beta-4.

Related PeptideStat pages

Put the record in context.

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