A PK & safety study of Regadenoson in CVD paediatric patients
Research type
Research Study
Full title
An Open-label, Single Ascending-dose, Pharmacokinetic and Safety Study of Regadenoson (Rapidscan®) in Paediatric Patients with Cardiovascular Conditions and Diseases
IRAS ID
194583
Contact name
Sujeev Mathur
Contact email
Sponsor organisation
Rapidscan Pharma Solutions EU Ltd (RPS EU Ltd)
Eudract number
2015-000500-26
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a study in 54 paediatric patients (male/female) with existing heart conditions and diseases. These patients are attending for a test on their heart using a drug to increase their heart rate and a scanning machine to look at how the heart responds. Adenosine is the drug commonly used to cause an increase in heart rate (stress test), and regadenoson is thought to have a similar effect.
The purpose of this study is to assess regadenoson (Rapiscan®) in infants, children and adolescents between the ages of 1 month to under 18 years of age. Specifically, to investigate what happens to the drug in the bodies of infants, children and young people; the safety of a single injection; and to identify the correct amount of drug that will be used in infants, children and adolescents.
Trial participants will be split into 3 groups, as follows: adolescents aged 12 to under 18 years (PART A), children aged 2 to under 12 years (PART B) and infants aged 1 to under 24 months (PART C). At least 6 patients will be enrolled at each dose level for each part.
PART A trial participants will be recruited first. They will attend the hospital for a heart scan. As part of the scanning procedure, they will be injected with adenosine, followed by gadolinium (a contrast agent, which allows for blood flow to be observed). Regadenoson will then be administered after the effects of adenosine have worn off (takes about 5 minutes) starting with a small dose of 1 microgram/kg, with dose escalation between groups of patients only after a review of the safety data. The dose will not exceed, 400 micrograms (the adult dose). Regadenoson will always be given in addition to adenosine, and will not be administered without it. PART B will only start after a review of safety of regadenoson in PART A. Patients will be asked to attend up to 3 visits: screening (which may be performed on the same day of the scan and when adenosine and regadenoson are given, or within 30 days before regadenoson is given); the day of the scan and when regadenoson is given; and finally, a follow-up telephone call or hospital visit, the day following the scan.
The study will be conducted at 2 study centres in the UK and the expected duration for each patient is 2 days. The patient could, however, be screened up to 30 days prior to the scan and receiving regadenoson, so then the duration could be up to 32 days in total, including follow up.REC name
London - Central Research Ethics Committee
REC reference
16/LO/0490
Date of REC Opinion
8 Aug 2016
REC opinion
Further Information Favourable Opinion