Status:
WITHDRAWN
A Study to Assess the Pharmacokinetics and Pharmacodynamics of JNJ-54452840 in Participants With Heart Failure and Anti-beta1-adrenergic Receptor Autoantibodies
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of JNJ-54452840 in participants with heart fail...
Detailed Description
This study will be randomized (the study treatment is assigned by chance), double-blind (neither investigator nor participant knows the treatment received), and placebo-controlled (one of the study tr...
Eligibility Criteria
Inclusion
- Must have documented medical history of symptomatic (ie, showing symptoms) reduced ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) heart failure due to either ischemic etiology (decreased blood supply to heart) or non-ischemic dilated cardiomyopathy (heart is weakened and enlarged) for at least 4 months prior to the screening visit
- Must have heart failure classified by the New York Heart Association classification system as class I through IIIa
- Must have a left ventricular ejection fraction (measurement of the percentage of blood leaving the heart each time it contracts) of \< = 45%
- Must have blood levels of anti-beta1-adrenergic receptor autoantibodies (antibodies that are involved in developing heart failure) that are above the reference range
- Must have been receiving guideline-directed medical therapy for heart failure for at least 4 months prior to screening and, in addition, be receiving stable and individually optimized drug doses for at least 2 months prior to screening.
Exclusion
- History of, or current active illness that, in the opinion of the investigator, would make participation not in the best interest (eg, compromise the well-being) of the patient or that could interfere with the study assessments
- Left ventricular end-diastolic diameter index (a measure of the heart's performance) of \<= 32 mm/m2
- N-terminal pro-brain natriuretic peptide level (a biologic molecule that has been shown to predict cardiac events) that is \<= 200 pg/mL in participants with normal sinus rhythm or \<= 800 pg/mL in participants with atrial fibrillation
- Chronic treatment with immunosuppressive drugs (except for \<= 5 mg/day prednisone-equivalent dose)
- Known allergies to peptides or proteins, such as albumin.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01798745
Start Date
November 1 2014
End Date
December 1 2015
Last Update
April 9 2014
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