Study of effectiveness and safety of a treatment for children with RSV

• Research type

  Research Study

• Full title

  A Phase 2, double-blind, placebo-controlled study to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different doses of JNJ-53718678 in children ≥28 days and ≤3 years of age with acute respiratory tract infection due to respiratory syncytial virus infection.

• IRAS ID

  246700

• Contact name

  Heidi Pelemans

• Contact email

  HPELEMAN@its.jnj.com

• Sponsor organisation

  Janssen Sciences Ireland UC

• Eudract number

  2016-003642-93

• Duration of Study in the UK

  1 years, 6 months, 10 days

• Research summary

  Summary of Research
  The purpose of this research study is to see how well and how safely a study medicine (called ‘JNJ-53718678’) works in children aged 28 days to three years old, and who have tested positive for an infection with respiratory syncytial virus (RSV). The study also looks at how much JNJ-53718678 is taken up in the blood, how long it stays there and how the body handles it.
  This study compares three treatments: a low dose of JNJ-53718678, a high dose of JNJ-53718678 and a dummy medicine (or ‘placebo’). All three treatments are liquids given for seven days (once a day) using an oral dosing pipette.
  The study is made up of three parts: screening period (1 day), treatment period (7 days) and follow-up period (21 days). At screening, a parent of the child with RSV signs the study informed consent form. Their child then undergoes various tests and assessments to see if they can enter the study. These include a nasal swab, an electrocardiogram, blood and urine test.
  If the child is eligible to take part, it will then be decided by chance which treatment they receive. There is a two in three chance that the child will receive JNJ-53718678, and a one in three chance that the child will receive placebo.
  During the treatment and follow-up periods, the child will have further tests and assessments, and will be continually monitored. Their parent or caregiver will be asked to complete a diary each day answering questions about their child’s RSV symptoms. If the child is discharged from hospital during this time, their parent will be asked to bring them back to clinic for study visits or the research team will visit the child at home. The JNJ-53718678/placebo will be stopped if a child experiences side effects which they cannot tolerate.

  Summary of Results
  There is no lay summary for this study

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  18/LO/1791

• Date of REC Opinion

  5 Dec 2018

• REC opinion

  Further Information Favourable Opinion