Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01016392 : Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency
PhaseN/A
AgesMin: 4 Years Max: N/A
Eligibility
Inclusion Criteria:

• Adult or pediatric subject (4 years old or older) of either gender with HPA due to PKU.

Or

- Adult or pediatric subject (no lower limit of age) of either gender with HPA due to
BH4 deficiency

- Have been shown to be responsive to BH4 or Kuvan. (Note: For Spain only-Have been
shown to be responsive to BH4 or for the newly diagnosed subjects to be responsive to
Kuvan as defined in the Summary of Product Characteristics [SmPC])

- Currently being treated with Kuvan® at a participating centre

- Subject or parent/legal guardian willing and able to provide written signed informed
consent and given before any data collection. If a child is old enough to read and
write, a separate assent form will be given

- Have been shown to be responsive to BH4 or for the newly diagnosed subjects fo be
responsive to Kuvan as defined in the SmPC

Exclusion Criteria:

- Known hypersensitivity to Kuvan®

- Legal incapacity or limited legal capacity without legal guardian representation

- Breast-feeding
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01016392      |      Link to official Clinicaltrials.gov listing
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