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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02596477




Registration number
NCT02596477
Ethics application status
Date submitted
30/10/2015
Date registered
4/11/2015
Date last updated
28/10/2016

Titles & IDs
Public title
Evaluation of Vepoloxamer in Chronic Heart Failure
Scientific title
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
Secondary ID [1] 0 0
MST-188-09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Vepoloxamer
Other interventions - 5% dextrose in water

Experimental: Vepoloxamer - Low dose - Vepoloxamer injection administered intravenously 225 mg/kg over 3 hours

Experimental: Vepoloxamer - High dose - Vepoloxamer injection administered intravenously 450 mg/kg over 3 hours

Placebo Comparator: 5% dextrose in water (D5W) - D5W administered intravenously over 3 hours


Treatment: Drugs: Vepoloxamer


Other interventions: 5% dextrose in water
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with a change in cardiac biomarkers ultra-high sensitive troponin I and NT-proBNP
Timepoint [1] 0 0
Study Day 1 through Study Day 30
Primary outcome [2] 0 0
Number of subjects with a change in Six Minute Walk test
Timepoint [2] 0 0
Study Day 1 to Study Day 30
Primary outcome [3] 0 0
Number of subjects with a change in Borg dyspnea index
Timepoint [3] 0 0
Study Day 1 to Study Day 30
Primary outcome [4] 0 0
Number of subjects with a change in Minnesota Living with Heart Failure Questionnaire®
Timepoint [4] 0 0
Study Day 1 to Study Day 30
Primary outcome [5] 0 0
Number of subjects with a change in left ventricular end diastolic volume index
Timepoint [5] 0 0
Study Day 1 to Study Day 30
Primary outcome [6] 0 0
Number of subjects with treatment-related adverse events as assessed by CTCAE v 4.03
Timepoint [6] 0 0
Study Day 1 to Study Day 30

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Center - Cardiff
Recruitment hospital [2] 0 0
Research Center - Melbourne
Recruitment postcode(s) [1] 0 0
2285 - Cardiff
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Michigan
Country [2] 0 0
United States of America
State/province [2] 0 0
Mississippi

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mast Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02596477
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edwin L. Parsley, D.O.
Address 0 0
Mast Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02596477