CHF5633 To Treat Respiratory Failure in Premature Babies V2.0 16/11/11

• Research type

  Research Study

• Full title

  A first in human clinical study on the safety and tolerability of two escalating single doses of CHF 5633 (Synthetic surfactant) in preterm neonates with respiratory distress syndrome

• IRAS ID

  98497

• Contact name

  Mark Turner

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2011-001331-22

• Research summary

  Clinical Study Protocol No.: CCD-1011-PR-0059 Study Title: ??A First In Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF5633 (Synthetic Surfactant) in Preterm Neonates with Respiratory Distress Syndrome?. Premature babies born between 27 and 33 weeks after the mother??s last menstrual cycle can be affected by Respiratory Distress Syndrome. In this condition the baby may not start breathing after birth or may not breathe very well due to a deficiency of flud that keeps the lungs open known as surfactant. Therefore, a replacement therapy is needed for their survival. Currently, the gold standard for treatment is a marketed product called Curosurf©, derived from pig lungs. Chiesi has developed a new synthetic surfactant (CHF 5633), which is similar to Curosurf©. It is not derived from animals and, hence, it is expected to reduce the potential problems of animal derived products. This study will be the first one using CHF 5633 in premature neonates suffering from Respiratory Distress Syndrome. The study is being done in the UK and Germany. The aim of this study is to make sure that this product is safe and the potential side effects are tolerable by the babies receiving it. Approximately, 40 premature babies will receive either a lower or higher dose of CHF 5633. The first group of 20 babies will receive the lower dose (100 mg/kg). If this dose is deemed safe and tolerable, a second group of 20 babies will receive the higher dose (200 mg/kg). After each single CHF 5633 administration, the neonatologist will have the choice to use Curosurf© as rescue treatment, in case of CHF 5633 lack of efficacy or safety concerns. Eventual side effects will be recorded and the data collected in the hours after each baby has been given the medicine and in the following 7 days. This data will be carefully monitored and reviewed by the clinical study team and by an independent expert neonatologist.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0149

• Date of REC Opinion

  17 May 2012

• REC opinion

  Further Information Favourable Opinion