Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure (RELAX-PEDS-PK)

Novartis

Status and phase: Terminated; Phase 2

Conditions: Acute Heart Failure

Treatments: Drug: Serelaxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02151383

CRLX030A2208

2013-002847-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study was 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)

Full description

The study was terminated early and the pediatric development of serelaxin in the treatment of acute heart failure (AHF) discontinued, following the results of the phase III study RELAX-AHF-2 (CRLX030A2301/NCT01870778) study in adult patients with AHF. Whilst no new safety concerns associated with serelaxin were observed, the study in adults did not meet either of its primary endpoints

Enrollment: 12 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Serelaxin

Experimental group

Description:

Serelaxin was administered intravenously on top of standard therapy for acute heart failure, for a total of 48 hours.

Treatment:

Drug: Serelaxin