HumRes50165
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SNCTP000003803
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BASEC2019-01352
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NCT05671666
Ureagenesis Analysis
Résumé de l'étude
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 étudiée
No intervention planned
(BASEC)
Maladie en cours d'investigation
Urea cycle disorders
(BASEC)
Critères de participation
Healthy Patients with urea cycle defect Written consent (BASEC)
Critères d'exclusion
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)
Critères d'exclusion
Acute or chronic illness requiring treatment Pregnancy Breastfeeding Intake of N-Carbamylglutamate (if intake cannot be interrupted for 1 day) (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Switzerland (ICTRP)
Sponsor
University Children's Hospital Zurich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Johannes Häberle
+41442495988
johannes.haeberle@clutterkispi.uzh.chUniversity Children's Hospital Zutich
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
02.10.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT05671666 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Ureagenesis analysis in healthy subjects and in urea cycle disorder patients (BASEC)
Titre académique
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Titre public
Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients (ICTRP)
Maladie en cours d'investigation
Urea Cycle Disorders (ICTRP)
Intervention étudiée
Diagnostic Test: Urea cycle flux study (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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 disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Johannes HberleJohannes Haeberle, Johannes.haeberle@kispi.uzh.chjohannes.haeberle@kispi.uzh.ch, 0041-442667342+41442667342 (ICTRP)
ID secondaires
Ureagenesis01352 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05671666 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible