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Clinical Trials/DRKS00004942
DRKS00004942
Recruiting
Not Applicable

Multicentre study about therapie management, nutrient supply and long-term outcome of patients with mild hyperphenylalaninemia and classical phenylketonuria - Therapy management of PK

niversität Leipzig0 sites50 target enrollmentJuly 9, 2013
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ConditionsE70.0E70.1Classical phenylketonuriaOther hyperphenylalaninaemias

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
E70.0
Sponsor
niversität Leipzig
Enrollment
50
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 9, 2013
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversität Leipzig

Eligibility Criteria

Inclusion Criteria

  • •Patients with mild hyperphenylalaninemia or phenylketonuria
  • •patients of both sexes with a minimum age of 4 year.
  • •At the clinical/ study visit the patient is clinically healthy except for the mild hyperphenylalaninemia and phenylketonuria.
  • •written informed consent of patient or and parents/ legal representative

Exclusion Criteria

  • •\-Inability to fulfill study criteria
  • •\-patients with psychiatric disorders
  • •\-atypical phenylketonuria
  • •\-blood loss of more than 500 ml in the last three months
  • •\-severe allergic diathesis
  • •\-severe organic diseases
  • •\-acute diseases at the study visit, especially acute infections
  • •\-Every chronic disease or results of surgery of gestive tract which may affected resorption, metabolism or excretion (e.g. pancreatic insufficiency,
  • •\-Refusal to give consent
  • •\-Other metabolic disorders except for mild hyperphenylalaninemia and phenylketonuria

Outcomes

Primary Outcomes

Not specified

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