EUCTR2011-002472-16-DEActive, not recruitingNot Applicable
Open, prospective, diagnostic, multicentre study in healthy subjects, patients with urea cycle disorders (UCD), and carriers of UCD mutations, to evaluate in vivo ureagenesis measured after a single application of Sodium [1,2-13C]-Acetate
Cytonet GmbH & Co KG0 sitesStarted: August 22, 2011Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •All study groups:
- •Written informed consent given by subjects or his/her parents/legal guardians who are able to understand and follow instructions related to the study
- •Age: 18 - 65 years
- •Healthy subjects
- •No clinical or laboratory parameter outside normal ranges at
- •screening and judged as clinically relevant by the investigator
- •Age: 0 - 65 years
- •Symptomatic subjects with genetically confirmed
- •Carbamylphosphate synthetase I Deficiency [CPSD]
- •Ornithine Transcarbamylase Deficiency [OTCD]
- •Argininosuccinate Synthetase Deficiency [Citrullinaemia type I]
- •Argininosuccinate Lyase Deficiency [ASLD]
- •at least 1 metabolic decompensation with clinical signs ofhyperammonemia in medical history or genetically confirmed and
- •prospectively treated siblings of symptomatic patients, even without clinical symptoms
- •Confirmed diagnosis and medical history available (in particular
- •number and severity of metabolic crises)
- •Age: 0 - 65 years
- •Asymptomatic carriers of mutations for
- •Carbamylphosphate synthetase I Deficiency [CPSD]
- •Ornithine Transcarbamylase Deficiency [OTCD]
- •Argininosuccinate Synthetase Deficiency [Citrullinaemia type 1]
- •Argininosuccinate Lyase Deficiency [ASLD]
- •no dietary protein restriction, no intake of ammonia scavenging drugs, no known metabolic decompensation with clinical signs of
- •hyperammonemia
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Acute illness, including vomiting, fever or other sign of infection
- •Participation in other invasive clinical trials within 30 days prior to
- •Liver or renal disease
- •Acute seizures
- •Bleeding disorder
- •Blood ammonia > 100 µmol/l for patients with a urea cycle disorder and blood ammonia > normal for healthy probands and asymptomatic carriers
- •Metabolic acidosis
- •Pregnancy or lactation
- •Body weight < 8 kg
Investigators
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