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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 - Trial NCT05598333

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.

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NCT05598333
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05598333
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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

Study Focus

Congestive Heart Failure

NAN-101

Interventional

drug

Sponsor & Location

Asklepios Biopharmaceutical, Inc.

Timeline & Enrollment

Phase 2

Dec 01, 2022

Dec 01, 2029

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 failure
Heart failure
Hypertensive heart disease with (congestive) heart failure
Hypertensive heart and renal disease with (congestive) heart failure
Heart failure, unspecified

Data Source

ClinicalTrials.gov

NCT05598333

Non-Device Trial