At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 59 enrolled
Drug / intervention
Kuvan®drug
Likely dose
Kuvan® 20 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ENDURE: A Phase IV, Prospective, Open-label, Uncontrolled, Multi-centre Cohort Trial to Assess the Responsiveness of Subjects With Phenylketonuria (PKU) to Treatment With Kuvan® 20 mg/kg/Day for 28 Days
In Brief
A Phase 4 clinical trial evaluating Kuvan® for Phenylketonuria. Completed, enrolled 59 participants across 1 site.
Detailed Summary
The primary objective of the study is to evaluate the proportion of responders (that is, greater than or equal to \[\>=\] 30 percent reduction from Baseline in blood phenylalanine \[Phe\] level) to treatment with Kuvan® (sapropterin dihydrochloride) 20 milligram per kilogram per day (mg/kg/day) for 28 days.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesNorway
CollaboratorsMerck Serono Norway, Smerud Medical Research International AS
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartMay 2010
Primary CompletionMay 2012
TodayJul 2026
First PostedMar 8, 2010
Enrollment StartMay 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.3 years ago
Interventions
Kuvan®drug
Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) will be given once daily for 28 +/- 1 days.