NCT02151383

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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

Conditions

• Acute Heart Failure

Interventions

Type	Name	Description
DRUG	Serelaxin	Serelaxin was administered intravenously for up to 48 hours.

Timeline

• Start date: 2014-09-05
• Primary completion: 2017-04-03
• Completion: 2017-04-03
• First posted: 2014-05-30
• Last updated: 2019-06-25
• Results posted: 2019-06-25

Locations

10 sites across 4 countries: United States, Germany, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study