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

Primary Purpose

Acute Myocardial Infarction, ST Elevation Myocardial Infarction, STEMI

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Drug: Placebo
Drug: Injectable Thymosin beta 4
Sponsored by
RegeneRx Biopharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Thymosin Beta 4, Thymosin β4 (Tβ4) Injectable Solution, RGN-352

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Drug: Thymosin Beta 4 injectable

    Arm Description

    Outcomes

    Primary Outcome Measures

    Total MRI infarct zone derived from cardiac MRI scan

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 7, 2011
    Last Updated
    September 15, 2021
    Sponsor
    RegeneRx Biopharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01311518
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Trial never initiated
    Study Start Date
    July 2019 (Anticipated)
    Primary Completion Date
    July 2020 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RegeneRx Biopharmaceuticals, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Myocardial Infarction, ST Elevation Myocardial Infarction, STEMI
    Keywords
    Thymosin Beta 4, Thymosin β4 (Tβ4) Injectable Solution, RGN-352

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Drug: Thymosin Beta 4 injectable
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Drug: Placebo
    Other Intervention Name(s)
    0.00% Thymosin Beta 4
    Intervention Description
    Injectable administration by slow intravenous bolus, 0.00% Thymosin Beta 4 daily for 3 days then weekly for 4 consecutive weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Drug: Injectable Thymosin beta 4
    Other Intervention Name(s)
    Injectable Thymosin Beta 4, Tβ4 Injectable Solution, RGN-352
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Total MRI infarct zone derived from cardiac MRI scan
    Time Frame
    Day 28
    Secondary Outcome Measure Information:
    Title
    MRI-derived myocardial salvage index, mass, Left Ventricle (LV) ejection fraction,systolic and end diastolic volumes
    Time Frame
    Day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    J.J. Finkelstein, BBA
    Organizational Affiliation
    RegeneRx Biopharmaceuticals, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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