HumRes50165
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SNCTP000003803
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BASEC2019-01352
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NCT05671666
Ureagenesis Analysis
Summary description of the study
The project concerns the introduction of a new test. This is intended to examine the function of the urea cycle and be more accurate than previous methods. The test takes several hours and requires drinking a salty solution, followed by several blood draws from a venous catheter.
(BASEC)
Intervention under investigation
No intervention planned
(BASEC)
Disease under investigation
Urea cycle disorders
(BASEC)
Criteria for participation in trial
Healthy Patients with urea cycle defect Written consent (BASEC)
Exclusion criteria
Acute or chronic illness requiring treatment Pregnancy Breastfeeding Intake of N-Carbamylglutamate (if intake cannot be interrupted for 1 day) (BASEC)
Healthy Patients with urea cycle defect Written consent (BASEC)
Exclusion criteria
Acute or chronic illness requiring treatment Pregnancy Breastfeeding Intake of N-Carbamylglutamate (if intake cannot be interrupted for 1 day) (BASEC)
Trial sites
Zurich
(BASEC)
Switzerland (ICTRP)
Sponsor
University Children's Hospital Zurich
(BASEC)
Contact
Contact Person Switzerland
Johannes Häberle
+41442495988
johannes.haeberle@clutterkispi.uzh.chUniversity Children's Hospital Zutich
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
02.10.2019
(BASEC)
ICTRP Trial ID
NCT05671666 (ICTRP)
Official title (approved by ethics committee)
Ureagenesis analysis in healthy subjects and in urea cycle disorder patients (BASEC)
Academic title
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Public title
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Disease under investigation
Urea Cycle Disorders (ICTRP)
Intervention under investigation
Diagnostic Test: Urea cycle flux study (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- healthy subjects at any age and given written informed consent
- subjects with a UCD confirmed by genetic or enzymatic diagnostics at any age and
given written informed consent
Exclusion Criteria:
- healthy subjects with acute and chronic disease requiring treatment of any kind
- pregnant or lactating women.
- UCD patients with acute and chronic (other than her/his UCD) disease requiring
treatment
- UCD patients in which intake of carglumic acid cannot be stopped for 24 hours prior
to the test (ICTRP)
not available
Primary and secondary end points
Rate of flux through the urea cycle using stable isotopes in healthy subjects and patients, and the change of rate of flux through the urea cycle in patients after an intervention or for follow-up. (ICTRP)
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Johannes HberleJohannes Haeberle, Johannes.haeberle@kispi.uzh.chjohannes.haeberle@kispi.uzh.ch, 0041-442667342+41442667342 (ICTRP)
Secondary trial IDs
Ureagenesis01352 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05671666 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available