Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure



Status:Terminated
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 17
Updated:10/28/2017
Start Date:September 5, 2014
End Date:April 3, 2017

Use our guide to learn which trials are right for you!

Multicenter, Open-label, Dose Escalation Study to Evaluate Safety, Tolerability and Pharmacokinetics of RLX030 in Addition to Standard of Care in Pediatric Patients From Birth to <18 Years of Age, Hospitalized With Acute Heart Failure

The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of an
intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients
with acute heart failure (AHF)


INCLUSION CRITERIA:

- Body weight ≥2.5 kg to ≤120 kg

- Hospitalized in an intensive care unit or step-down unit with the following:

- - Signs and symptoms of acute heart failure of any etiology

- - Stable dose of vasoactive and/or inotropic drugs

- - For non-surgical patients echocardiographic evidence of reduced ventricular function
(ejection fraction <50% or fractional shortening <28%)

- Systolic blood pressure (SBP) ≥25th percentile SBP for age and gender.

EXCLUSION CRITERIA:

- Moderate to severe left ventricular outflow tract, mitral stenosis, or aortic arch
obstruction

- Single ventricle physiology

- Fixed pulmonary hypertension

- Blood lactate levels >5 mmol/L at screening

- Birth < 36 weeks post-conceptual age (for patients <1year old)

- Confirmed or clinically suspected systemic infection or severe localized infection

- Dyspnea or acute lung injury primarily due to non-cardiac causes

- Patients with severe renal impairment, those known to have significant renal disease
and those having renal replacement therapy

- High use of inotropic and/or vasoactive agents at screening

- Electrocardiographic abnormalities

- Solid organ transplant recipient within 1 year of transplantation or one who presents
with severe organ rejection

Other protocol defined inclusion/exclusion criteria may apply.
We found this trial at
6
sites
?
mi
from
Berlin,
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Denver, Colorado 80262
?
mi
from
Denver, CO
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19102
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Saint Louis, Missouri 63128
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
The Bronx, New York 10467
?
mi
from
The Bronx, NY
Click here to add this to my saved trials