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Novel INXN-4001 Triple Effector Plasmid in Heart Failure

NCT03409627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-12-04

No results posted yet for this study

Summary

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).

Conditions

Interventions

BIOLOGICAL

INXN-4001

Retrograde coronary sinus infusion of triple effector plasmid (INXN-4001)

Sponsors & Collaborators

  • Intrexon Corporation

    collaborator INDUSTRY

  • Precigen, Inc

    collaborator INDUSTRY

  • Triple-Gene, LLC

    lead INDUSTRY

Principal Investigators

  • David Bull, MD · University of Arizona

  • Ulrich Jorde, MD · Montefiore Medical Center

  • Gregory Egnaczyk, MD · The Christ Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2020-03-04
Completion
2020-08-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03409627 on ClinicalTrials.gov