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Trial · Interventional

WithdrawnPhase 2Registry data

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

NCTNCT01311518 (opens ClinicalTrials.gov in a new tab)Other idRGN-MI-201
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
RegeneRx Biopharmaceuticals, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
Not stated
Start
Jul 2019 (estimated)
Primary completion
Jul 2020 (estimated)
Completion
Jul 2020 (estimated)
First posted
9 Mar 2011 (estimated)
Last update posted
22 Sept 2021
Conditions
Acute Myocardial Infarction · ST Elevation Myocardial Infarction · STEMI

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 2

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

    NCT01311518

    est. Jul 2019 to est. Jul 2020

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Drug: PlaceboDrug
  • Drug: Injectable Thymosin beta 4Drug

Arms2

  • Placebo comparator

    Placebo

  • Active comparator

    Drug: Thymosin Beta 4 injectable

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Total MRI infarct zone derived from cardiac MRI scan

    Time frame · Day 28

Secondary outcomes(1)

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

    Time frame · Day 28

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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