HumRes50165
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SNCTP000003803
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BASEC2019-01352
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NCT05671666
Ureagenesis Analysis
Zusammenfassung der Studie
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)
Untersuchte Intervention
No intervention planned
(BASEC)
Untersuchte Krankheit(en)
Urea cycle disorders
(BASEC)
Kriterien zur Teilnahme
Healthy Patients with urea cycle defect Written consent (BASEC)
Ausschlusskriterien
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)
Ausschlusskriterien
Acute or chronic illness requiring treatment Pregnancy Breastfeeding Intake of N-Carbamylglutamate (if intake cannot be interrupted for 1 day) (BASEC)
Studienstandort
Zürich
(BASEC)
Switzerland (ICTRP)
Sponsor
University Children's Hospital Zurich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Johannes Häberle
+41442495988
johannes.haeberle@clutterkispi.uzh.chUniversity Children's Hospital Zutich
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
02.10.2019
(BASEC)
ICTRP Studien-ID
NCT05671666 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Ureagenesis analysis in healthy subjects and in urea cycle disorder patients (BASEC)
Wissenschaftlicher Titel
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Öffentlicher Titel
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Untersuchte Krankheit(en)
Urea Cycle Disorders (ICTRP)
Untersuchte Intervention
Diagnostic Test: Urea cycle flux study (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Johannes HberleJohannes Haeberle, Johannes.haeberle@kispi.uzh.chjohannes.haeberle@kispi.uzh.ch, 0041-442667342+41442667342 (ICTRP)
Sekundäre IDs
Ureagenesis01352 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05671666 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar