CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Kuvan +1 moredrug
Likely dose
Kuvan 20mg/kgfrom 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.

Search/NCT00841100
NCT00841100Phase 2Completed
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Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response

University of Miami·interventional·Posted Feb 11, 2009·Updated Dec 3, 2019

In Brief

A Phase 2 clinical trial evaluating Kuvan and Diet for Phenylketonuria. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet. Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will increase the frequency of Kuvan responsiveness.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhenylketonuria
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 11, 2009
Enrollment StartDec 1, 2008
Primary CompletionJul 19, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.4 years ago

Interventions

Kuvandrug

20mg/kg by mouth once daily

Dietother

Phenylalanine-restricted diet (4-10 mg/kg/day phenylalanine) using the prescribed phenylalanine-free medical formula and low protein foods tested with the patients for taste and acceptance to lower blood phenylalanine levels below 600 umol/l.