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Your journey
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More info
You can access this
clinical trial
if you have
Phenylketonuria
and you are
between 4 and 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal to 450 micromole per liter.

Provided treatments

  • Drug: Kuvan®

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01732471. The sponsor of the trial is Merck KGaA and it is looking for 90 volunteers for the current phase.
Official trial title:
A Phase III Non-comparative Open-label Clinical Study to Evaluate the Response to and Safety of Kuvan (Sapropterin Dihydrochloride) After 6 Weeks of Treatment in Patients of 4 to 18 Years of Age With Phenylketonuria Who Have Elevated Blood Phenylalanine Levels