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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	4 August 2015
Main ID:	EUCTR2010-019767-11-AT
Date of registration:	10/08/2010
Prospective Registration:	Yes
Primary sponsor:	Graz Medical University
Public title:	Ö-PKU 1 – Evaluation of a Test for the identication of BH4 responsive PKU patients - Ö-PKU1
Scientific title:	Ö-PKU 1 – Evaluation of a Test for the identication of BH4 responsive PKU patients - Ö-PKU1
Date of first enrolment:	08/09/2010
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019767-11
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: two tests
Phase:

Countries of recruitment
Austria

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- PAH deficiency proven by new born screening
- known BH4 responsive genotype
- 4-18 years of age
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- atypical PKU
- contraindication for Kuvan
- relevant non-compliance
- intake of study drug less than 2 weeks befor study

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hyperphenylalaninaemia (HPA) in adult and paediatric patients of 4 years of age and over with phenylketonuria (PKU).

Intervention(s)

Trade Name: Kuvan
Pharmaceutical Form: Soluble tablet

Primary Outcome(s)

Secondary Objective: - responsive genotypes
- correlation of initial blood phe levels and results in the two respective tests
- frequency of deviations from blood phenylalanine target range in both tests
- frequency and reasons for deviations from test algorithm

Main Objective: Evaluation of a test to identify BH4 responsive Patients.

Primary end point(s): Consistnacy of findings in the two respective tests

Secondary Outcome(s)

Secondary ID(s)

Ö-PKU1

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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