Novel INXN-4001 Triple Effector Plasmid in Heart Failure

Completed · Phase 1

Conditions studied: Heart Failure, Cardiovascular Diseases, Heart-Assist Device

In brief

To evaluate the safety of retrograde coronary sinus infusion (RCSI) of a novel triple-effector plasmid (INXN-4001) in outpatient LVAD recipients as assessed by incidence of all study intervention-related adverse events occurring up to 6 months post-RCSI (primary endpoints), and to evaluate general safety by assessing incidence of cardiac specific adverse events and the incidence of related serious adverse events at intervals up to 12 months post-infusion (or until cardiac transplantation or death).

Key facts

Study ID

NCT03409627

Run by

Triple-Gene, LLC

People needed

12

Starts

2018-04-09

Expected to finish

2020-08-12

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adult patients with a stable LVAD implanted for end-stage heart failure
• Must be managed in an outpatient setting and on stable medication regimen

You may not qualify if…

• Women who are pregnant or nursing
• Patients who have been on another clinical trial for heart failure in the last 90 days, or have received any stem cell or gene therapy within the previous year.
• Patient is not able to complete a Six Minute Walk Test or unable to tolerate an LVAD wean in the past 3 months
• Patient has an active infection requiring systemic antibiotics or an autoimmune disease requiring systemic immunosuppressants
• Patient has a history of arrhythmia, uncontrolled diabetes, diabetic retinopathy, systemic lupus erythematosus, macular degeneration, hyper-coagulation, or stroke
• Patient has had a myocardial infarction related to ischemia within the past 30 days
• Patient has had certain prior surgeries such as organ transplant, cardiac transplantation, left ventricle reduction surgery, or cardiomyoplasty
• Patient has infectious disease, such as hepatitis B or C, or human immunodeficiency virus (HIV)
• Patient has a history of cancer within the past 3 years

Where it is running

• University of Arizona Sarver Heart Center — Tucson, Arizona, United States
• The Lindner Research Center, The Christ Hospital Health Network — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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