Status:
COMPLETED
Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment
Lead Sponsor:
Cytonet GmbH & Co. KG
Conditions:
Urea Cycle Disorders
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with...
Eligibility Criteria
Inclusion
- Group 1 + 2: Healthy subjects
- Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders
- All: age 18 to 50 years (adult)
- Written informed consent
Exclusion
- Presence of acute infection
- Participation in other clinical trials within 30 days prior to inclusion
- Severe coagulopathy
- Severe systemic or chronic disease
- Pregnancy or lactation
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01002469
Start Date
September 1 2009
End Date
December 1 2009
Last Update
January 15 2010
Active Locations (1)
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1
CRS Clinical Research Services Mönchengladbach GmbH
Mönchengladbach, Germany, 41061