Paediatric study of Intrathecal Idursulfase-IT with Elaprase®

• Research type

  Research Study

• Full title

  A Controlled, Randomized, Two-arm, Open-label, Assessor-blinded, Multicenter Study of Intrathecal Idursulfase-IT Administered in Conjunction with Elaprase® in Pediatric Patients with Hunter Syndrome and Early Cognitive Impairment

• IRAS ID

  134510

• Contact name

  Lynne Webster

• Contact email

  lynne.webster@cmft.nhs.uk

• Sponsor organisation

  Shire Human Genetic Therapies, Inc.

• Eudract number

  2013-002885-38

• REC name

  HSC REC B

• REC reference

  13/NI/0163

• Date of REC Opinion

  22 Oct 2013

• REC opinion

  Favourable Opinion