Evaluation of Vepoloxamer in Chronic Heart Failure

October 26, 2016 updated by: Mast Therapeutics, Inc.

A Phase 2 Randomized, Double-Blind, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Vepoloxamer Injection, 22.5% (Sodium-Free) in Ambulatory Subjects With Chronic Heart Failure

The purpose of this study is to evaluate whether vepoloxamer can provide a blood chemical marker and functional benefit to damaged heart muscle cells. This will be evaluated by measurement of blood-based laboratory markers, exercise tolerance, and echocardiograms. In addition, the safety and blood levels of vepoloxamer in subjects with chronic heart failure will be evaluated.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Cardiff, New South Wales, Australia, 2285
        • Research Center
    • Victoria
      • Melbourne, Victoria, Australia
        • Research Center
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Center
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 through 74
  • Duration of documented heart failure >3 months
  • On stable concomitant medication regimen ≥4 weeks
  • Left ventricular ejection fraction ≤35%
  • Systolic blood pressure ≥90 mmHg

Exclusion Criteria:

  • Severe valvular stenosis or primary valvular regurgitation as the cause of heart failure
  • History of myocardial infarction, coronary artery bypass graft surgery, or percutaneous intervention within the prior 3 months
  • Estimated glomerular filtration rate ≤45 mL/min/1.73 m2
  • Acutely decompensated heart failure within 1 month prior to the screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vepoloxamer - Low dose
Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours
Drug: Vepoloxamer
Experimental: Vepoloxamer - High dose
Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours
Drug: Vepoloxamer
Placebo Comparator: 5% dextrose in water (D5W)
D5W administered intravenously over 3 hours
Other: 5% dextrose in water
Other Names:
  • D5W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
Time Frame: Study Day 1 through Study Day 30
Study Day 1 through Study Day 30
Number of subjects with a change in Six Minute Walk test
Time Frame: Study Day 1 to Study Day 30
Study Day 1 to Study Day 30
Number of subjects with a change in Borg dyspnea index
Time Frame: Study Day 1 to Study Day 30
Study Day 1 to Study Day 30
Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®
Time Frame: Study Day 1 to Study Day 30
Study Day 1 to Study Day 30
Number of subjects with a change in left ventricular end diastolic volume index
Time Frame: Study Day 1 to Study Day 30
Study Day 1 to Study Day 30
Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03
Time Frame: Study Day 1 to Study Day 30
Study Day 1 to Study Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mast Therapeutics, Inc.

Investigators

  • Study Director: Edwin L. Parsley, D.O., Mast Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 30, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MST-188-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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