NCT01376908 - Kuvan® in Phenylketonuria Patients Less Than 4 Years Old | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

July 31, 2014

Study Completion Date

February 17, 2017

Conditions

Phenylketonuria

Interventions

DRUG

Kuvan®

Kuvan® (sapropterin dihydrochloride) tablets will be administered orally at the dose of 10 mg/kg/day and will be escalated to 20 mg/kg/day if after 4 weeks a subject's Phe tolerance is not increased by at least 20% versus baseline.

OTHER

Phenylalanine (Phe)-restricted diet

Phe intake will be adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.

Trial Locations (22)

Unknown

Research Site, Graz

Research site, Innsbruck

Research Site, Brussels

Research Site, Edegem

Research Site, Prague

Research site, Heidelberg

Research Site, Munich

Research Site, Münster

Research Site, Reutlingen

Research Site, Bologna

Research Site, Milan

Research Site, Padua

Research Site, Roma

Research site, Rome

Research Site, Amsterdam

Research Site, Maastricht

Research Site, Banská Bystrica

Research Site, Bratislava

Research Site, Košice

Research Site, Ankara

Research Site, Birmingham

Research site, London