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Clinical Trials/EUCTR2009-012978-12-NO
EUCTR2009-012978-12-NO
Active, not recruiting
Phase 1

A Phase IV, prospective, open-label, uncontrolled, single-centre cohort trial to be conducted in Norway to assess the responsiveness of subjects with phenylketonuria (PKU) to treatment with Kuvan® 20 mg/kg/day for 7 days. - Response to Kuvan® in subjects with PKU from a single centre in Norway

Merck Serono, an affiliate of E. Merck AB0 sitesJune 2, 2009
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ConditionsHyperphenylalaninemia (HPA) in adults and children >=16 years of age with phenylketonuri (PKU) (classic or mild PKU, or mild hyperphenylalaninemia (HPA)).MedDRA version: 9.1Level: LLTClassification code 10034872Term: PhenylketonuriaMedDRA version: 9.1Level: LLTClassification code 10034873Term: Phenylketonuria (PKU)MedDRA version: 9.1Level: PTClassification code 10034872Term: PhenylketonuriaMedDRA version: 9.1Level: LLTClassification code 10034871Term: Phenylalaninemia
DrugsKuvan® (sapropterin dihydrochloride)

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hyperphenylalaninemia (HPA) in adults and children >=16 years of age with phenylketonuri (PKU) (classic or mild PKU, or mild hyperphenylalaninemia (HPA)).
Sponsor
Merck Serono, an affiliate of E. Merck AB
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2009
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Merck Serono, an affiliate of E. Merck AB

Eligibility Criteria

Inclusion Criteria

  • •Subjects will be included if they meet the following requirements:
  • •aged between \=16 years and 65 years at the screening visit
  • •diagnosed with PKU (classic PKU, mild PKU or mild HPA)
  • •previously untreated with sapropterin dihydrochloride
  • •baseline blood PHE measurement \=400 µmol/L
  • •agreed to comply with study procedures
  • •provided written informed consent.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Main exclusion criteria are:
  • •documented BH4 deficiency
  • •pregnant, planning pregnancy or breastfeeding.

Outcomes

Primary Outcomes

Not specified

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