NCT01376908
Phenylketonuria
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.
This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with phenylketonuria (PKU).
All
Up to 4 Years
No
Kuvan®, Phenylalanine (Phe)-restricted diet
Phase 3
Interventional
56
2011-06
2017-09-15
Graz, , Austria
Innsbruck, , Austria
Bruxelles, , Belgium
Edegem, , Belgium
Praha 10, , Czechia
Heidelberg, , Germany
Munich, , Germany
Münster, , Germany
Reutlingen, , Germany
Bologna, , Italy
Milano, , Italy
Padova, , Italy
Roma, , Italy
Rome, , Italy
Amsterdam, , Netherlands
Maastricht, , Netherlands
Banska Bystrica, , Slovakia
Bratislava, , Slovakia
Kosice, , Slovakia
Ankara, , Turkey
Birmingham, , United Kingdom
London, , United Kingdom
1. The BH4 dose was 20 milligram per kilogram per day (mg/kg/day)
2. The duration of the test was at least for 24 hours
3. A 30% decrease in blood Phe levels.
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