Calcium Up-Regulation by Percutaneous Administration of Gene Therapy In Cardiac Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Congestive Heart Failure
- Heart Failure
- Heart Failure Systolic
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
The CUPID-3 Trial is an interventional study of SRD-001, an adeno-associated virus serotype 1 (AAV1) vector expressing the transgene for sarco(endo)plasmic reticulum Ca2+ ATPase 2a isoform (SERCA2a), in anti-AAV1 neutralizing antibody (NAb) negative subjects with ischemic or non-ischemic cardiomyopa...
The CUPID-3 Trial is an interventional study of SRD-001, an adeno-associated virus serotype 1 (AAV1) vector expressing the transgene for sarco(endo)plasmic reticulum Ca2+ ATPase 2a isoform (SERCA2a), in anti-AAV1 neutralizing antibody (NAb) negative subjects with ischemic or non-ischemic cardiomyopathy and New York Heart Association (NYHA) class III/IV symptoms of heart failure with reduced ejection fraction (HFrEF). The Phase 1 trial is an open-label, uncontrolled study investigating one dose of SRD-001 at 3E13 viral genomes (vg) in 3 to 6 subjects. The Phase 2 is a randomized, double-blind, placebo-controlled trial with prospective assignment to a single dose of either SRD-001 at 3E13 vg or placebo in a 1:1 ratio and a total sample size of N=50.
Tracking Information
- NCT #
- NCT04703842
- Collaborators
- Covance
- Investigators
- Not Provided
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