SPARK (Safety Paediatric efficAcy phaRmacokinetic with Kuvan®)

• Research type

  Research Study

• Full title

  A Phase IIIb, Multicentre, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan®) in Phenylketonuria (PKU) Patients 4 Years Old.

• IRAS ID

  59633

• Contact name

  Suresh Vijayaraghagavan (Vijay)

• Sponsor organisation

  Merck Serono, S.A Geneva

• Eudract number

  2009-015768-33

• ISRCTN Number

  N/A

• Research summary

  Kuvan© received European Union (EU) marketing authorisation on 2 December 2008 for the treatment of hyperphenylalaninemia (HPA) in adult and paediatric patients 4 years of age and over with phenylketonuria (PKU) who have been shown to be responsive to such treatment.As per request by the European Medicines Authority, the purpose of this study is to expand that age range to infants and children with PKU who are younger than 4 years of age at the time of entry into this multicentre study.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/105

• Date of REC Opinion

  4 Jan 2011

• REC opinion

  Further Information Favourable Opinion