A PK Study of Serelaxin in Paediatric Heart Failure Patients

• Research type

  Research Study

• Full title

  A multicentre, open-label, dose escalation study to evaluate safety, tolerability and pharmacokinetics of RLX030 in addition to standard of care in paediatric patients from birth to <18 years of age, hospitalised with acute heart failure.

• IRAS ID

  148200

• Contact name

  Dr Michael Burch

• Contact email

  Michael.Burch@gosh.nhs.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2013-002847-28

• Duration of Study in the UK

  years, 15 months, days

• Research summary

  The purpose of this study is to provide short-term safety information, including information on how serelaxin is processed by the body, in the paediatric patient population from birth to <18 years of age. Results from this study will be used to guide dose selection for the serelaxin paediatric development programme, including a Phase 3 double-blind, randomised, placebo-controlled long-term safety and efficacy study in paediatric patients. Patients will receive up to three different doses of intra-venous open-label serelaxin and be in the study for 28 days. It is hoped that in the UK, six patients will be recruited in three centres.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  14/LO/1179

• Date of REC Opinion

  7 Oct 2014

• REC opinion

  Further Information Favourable Opinion