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A Phase 1/2 Study of High-dose Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure

NCT02346422 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2017-01-31

No results posted yet for this study

Summary

The purpose of this trial is to characterize the safety profile and preliminary activity of high-dose MYDICAR® in persons with advanced heart failure when added to their maximal and optimized therapy.

Conditions

  • Ischemic Cardiomyopathy
  • Non-ischemic Cardiomyopathy
  • Heart Failure
  • Cardiomyopathies

Interventions

GENETIC

MYDICAR Phase 1

Single dose of MYDICAR

GENETIC

MYDICAR Phase 2

Single dose of MYDICAR

GENETIC

Placebo Phase 2 only

Single dose of placebo

Sponsors & Collaborators

  • Celladon Corporation

    lead INDUSTRY

Principal Investigators

  • Call 1-858-366-4081 · Celladon Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-06-26

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 NCT02346422 on ClinicalTrials.gov