Study in infants and toddlers with Respiratory Syncytial Virus

• Research type

  Research Study

• Full title

  A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead-in Part Followed by a Doubleblind, Placebo-controlled Part, to Evaluate the Safety, Tolerability and Clinical Activity of ALX-0171, Administered via Inhalation, in Addition to Standard of Care

• IRAS ID

  161871

• Contact name

  Dr Steve Cunningham

• Contact email

  steve.cunningham@nhs.net

• Sponsor organisation

  Ablynx NV

• Eudract number

  2014-002841-23

• Clinicaltrials.gov Identifier

  NCT02309320

• Clinicaltrials.gov Identifier

  NIHR CRN, CHIL - 3670

• Research summary

  This is a clinical Study of an experimental drug called ALX-0171 which is being investigated as treatment for lower respiratory tract infection (chest infection) caused by a virus called respiratory syncytial virus (RSV) in infants admitted to hospital.
  All infants will receive standard treatment for their chest infection and for some infants the experimental drug will be added on top to see if it is safe and effective in treating the virus.
  Respiratory syncytial virus (RSV) causes severe chest infections, mainly in infants during the winter and is estimated to infect 64 million people each year, resulting in 160,000 deaths.

  Infants will only be included if their parents voluntarily give their written informed consent for their infant to be included, and it is entirely the parents’ choice whether they give their consent or not.
  If parents do not want their child included, the infant will receive the normal, standard care provided by their hospital to treat the chest infection.

  As this experimental drug has not yet been tested in children, only 5 infants initially will receive 3 doses of ALX-0171, they will be closely monitored and all the information about how these infants do will be examined by a panel of experts.
  If the panel of experts are satisfied there may be a benefit for infants with chest infection caused by RSV, a further 30 infants will receive 3 doses ALX-0171, the study drug.
  Of the 30 infants, two thirds will receive the experimental drug, and one third will receive an ineffective placebo (dummy drug) on top of the standard care to see if it is safe and effective in treating the virus. No-one will know which treatment the infants will be receiving to ensure the results will be reliable.

• REC name

  HSC REC A

• REC reference

  14/NI/1075

• Date of REC Opinion

  16 Sep 2014

• REC opinion

  Further Information Favourable Opinion