HumRes50165
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SNCTP000003803
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BASEC2019-01352
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NCT05671666
Ureagenesis Analysis
Descrizione riassuntiva dello studio
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)
Intervento studiato
No intervention planned
(BASEC)
Malattie studiate
Urea cycle disorders
(BASEC)
Criteri di partecipazione
Healthy Patients with urea cycle defect Written consent (BASEC)
Criteri di esclusione
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)
Criteri di esclusione
Acute or chronic illness requiring treatment Pregnancy Breastfeeding Intake of N-Carbamylglutamate (if intake cannot be interrupted for 1 day) (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Switzerland (ICTRP)
Sponsor
University Children's Hospital Zurich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Johannes Häberle
+41442495988
johannes.haeberle@clutterkispi.uzh.chUniversity Children's Hospital Zutich
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
02.10.2019
(BASEC)
ID di studio ICTRP
NCT05671666 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Ureagenesis analysis in healthy subjects and in urea cycle disorder patients (BASEC)
Titolo accademico
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Titolo pubblico
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Malattie studiate
Urea Cycle Disorders (ICTRP)
Intervento studiato
Diagnostic Test: Urea cycle flux study (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Johannes HberleJohannes Haeberle, Johannes.haeberle@kispi.uzh.chjohannes.haeberle@kispi.uzh.ch, 0041-442667342+41442667342 (ICTRP)
ID secondari
Ureagenesis01352 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05671666 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile