NCT05598333

A Phase 2, Adaptive, Double-blinded, Placebo Controlled, Randomized, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Intracoronary Infusion of NAN-101 in Adult Subjects With New York Heart Association (NYHA) Class III Heart Failure and Non-ischemic Cardiomyopathy

Asklepios Biopharmaceutical, Inc.·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Congestive Heart Failure
Drug/Device/Intervention
NAN-101
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Asklepios Biopharmaceutical, Inc.
Timeline & enrollment
Phase
Phase 2
Start date
Dec 01, 2022
End date
Dec 01, 2029
Enrollment
150 participants
Primary outcome

Cardiovascular Related Death,NYHA Classification,Left Ventricular Ejection Fraction,Peak Oxygen Update (VO2),Six Minute Walk Test

Summary

This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center
 trial study to evaluate the safety and efficacy of a single dose of NAN-101, administered via
 antegrade intracoronary artery infusion, in males and females age 18 years with non-ischemic
 cardiomyopathy and NYHA Class III symptoms of HF.
 
 Subjects will be randomized into one of three treatment groups in a 1:1:1

ICD-10 classifications
Congestive heart failureHeart failureHypertensive heart disease with (congestive) heart failureHypertensive heart and renal disease with (congestive) heart failureHeart failure, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05598333
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05598333 through Pure Global AI's free database. This Phase 2 trial is sponsored by Asklepios Biopharmaceutical, Inc. and is currently Not yet recruiting. The study focuses on Congestive Heart Failure. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.