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Clinical trials for Amino acid metabolism

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: Amino acid metabolism. Displaying page 1 of 1.
    EudraCT Number: 2006-006440-55 Sponsor Protocol Number: Amino Acid 01/2007 Start Date*: 2007-08-27
    Sponsor Name:University Childrin's Hospital
    Full Title: Effect on metabolic acidosis due to hyperammonemia of high versus low intake of amino acid in VLBW infants.
    Medical condition: At birth, a VLBW infant is abruptly disconnected from the ideal source of parenteral nutrition - the placenta. If the goal of post-natal nutrition in the VLBW infant is to mimic in utero nutrition....
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063258 Amino acid level LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001045-14 Sponsor Protocol Number: SAF001 Start Date*: 2013-04-22
    Sponsor Name:Promethera Biosciences
    Full Title: SAF 001: A long-term safety follow-up study of patients suffering from Urea Cycle disorders (UCD) or Crigler-Najjar Syndrome (CN) having received infusions of HepaStem.
    Medical condition: Crigler-Najjar syndrome is associated with a complete or partial hepatic deficit of bilirubin glucuronosyltransferase activity and is apparent during the neonatal period by intense jaundice. The ur...
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004850 10021601 Inborn error of metabolism NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) PT (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-004639-24 Sponsor Protocol Number: STUDIO L-ARGININA Start Date*: 2005-10-24
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: Pharmacological intervention study with L-arginin in prevention of diabete type II in patients affected by metabolic syndrome.
    Medical condition: metabolic syndrome treatment for diabet type II prevention
    Disease: Version SOC Term Classification Code Term Level
    6.1 10037008 HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000075-27 Sponsor Protocol Number: HPN-100-021 Start Date*: 2016-03-07
    Sponsor Name:Horizon Therapeutics, LLC
    Full Title: A Randomised, Controlled, Open-Label Parallel Arm Study of the Safety, Pharmacokinetics and Ammonia Control of RAVICTI® (Glycerol Phenylbutyrate [GPB]) Oral Liquid and Sodium Phenylbutyrate (NaPBA)...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000161833 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-001733-86 Sponsor Protocol Number: 1710 Start Date*: 2014-10-15
    Sponsor Name:Maastricht University
    Full Title: The effect of L-arginine on brown adipose tissue metabolism in South Asian and white Caucasian subjects
    Medical condition: Obesity, glucose intolerance, endothelial dysfunction
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002472-16 Sponsor Protocol Number: CCD09 Start Date*: 2011-12-19
    Sponsor Name:Cytonet GmbH & Co KG
    Full Title: 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 singl...
    Medical condition: 1. Healthy subjects 2. Symptomatic UCD patients with genetically confirmed CPSD, OTCD, ASSD, or ASLD 3. Asymptomatic carriers of UCD mutations (e.g. parents)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005015-17 Sponsor Protocol Number: GE09-01 Start Date*: 2009-05-13
    Sponsor Name:VU university medical centre
    Full Title: Effect of N-acetylcysteine on thiopurine related hepatotoxicity in IBD patients
    Medical condition: adult patients (18-70 years old) who have been treated with azathioprine, 6-mercaptopure or 6-thioguanine for inflammatory bowel disease, in whom hepatotoxicity occured as an adverse event, are eli...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003638-28 Sponsor Protocol Number: 2015/576 Start Date*: 2015-09-30
    Sponsor Name:Aarhus University Hospital
    Full Title: ALOSTRA Alendronate treatment of osteoporosis in rheumatoid arthritis – indication and duration. A randomized, doubleblind, placebocontrolled multi-centre study to evaluate the effects of disconti...
    Medical condition: Rheumatoid arthritis and osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10031289 Osteoporosis, unspecified LLT
    20.0 100000004859 10039076 Rheumatoid arthritis and other inflammatory polyarthropathies LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000650-11 Sponsor Protocol Number: HEP002 Start Date*: 2014-09-15
    Sponsor Name:Promethera Biosciences
    Full Title: A prospective, open label, multicountry, efficacy and safety study of several infusions of HepaStem in Urea Cycle Disorders pediatric patients.
    Medical condition: The urea cycle disorders are inborn errors of metabolism that affect the transfer of nitrogen into urea. There are seven disorders to be investigated: carbamoylphosphate synthetase I deficiency [CP...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-003460-38 Sponsor Protocol Number: HPN-100-009 Start Date*: 2016-11-21
    Sponsor Name:Horizon Therapeutics, LLC
    Full Title: An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI®) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-001081-38 Sponsor Protocol Number: ARCT-810-03 Start Date*: 2021-12-23
    Sponsor Name:Arcturus Therapeutics, Inc.
    Full Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Nested Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARCT-810 in Adolescent and Adult ...
    Medical condition: Ornithine transcarbamylase deficiency
    Disease: Version SOC Term Classification Code Term Level
    26.0 100000004850 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) ES (Completed) FR (Completed) SE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000022-63 Sponsor Protocol Number: 1-10-72-393-12 Start Date*: 2013-03-15
    Sponsor Name:Aarhus University
    Full Title: Acyl and desacyl ghrelin: The Yin and Yang of glucose homeostasis and insulin sensitivity? -Acute metabolic effects of desacyl ghrelin in insulin resistant patients
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    16.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-003283-31 Sponsor Protocol Number: NL67170.068.18 Start Date*: 2019-03-13
    Sponsor Name:School of Nutrition and Translational research in Metabolism (NUTRIM), Maastricht University
    Full Title: MaasFlex: A Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study to Evaluate the Effects of 2 Weeks Dapagliflozin Treatment on Nocturnal Substrate Ox...
    Medical condition: Study to investigate the effect of dapagliflozin treatment on nocturnal substrate oxidation in overweight and obese subjects with a disrupted glucose homeostasis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-000136-27 Sponsor Protocol Number: CCD02 Start Date*: 2008-03-17
    Sponsor Name:Cytonet GmbH & Co KG
    Full Title: Open, Prospective, Uncontrolled, Multicentre Study to Evaluate The Safety and Efficacy of Multiple Applications of Liver Cell Suspension Into The Portal Vein in Children with Urea Cycle Disorders (...
    Medical condition: Neonates and Infants up to 3 months including with prenatally or postnatally confirmed urea cycle disorder with below listed deficiency and children aged > 3 months up to 5 years including with con...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10052450 Ornithine transcarbamoylase deficiency PT
    18.1 10010331 - Congenital, familial and genetic disorders 10058298 Argininosuccinate synthetase deficiency PT
    18.1 10010331 - Congenital, familial and genetic disorders 10058297 Carbamoyl phosphate synthetase deficiency PT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-002857-18 Sponsor Protocol Number: H9P-MC-LNBI Start Date*: 2009-02-06
    Sponsor Name:Eli Lilly and Company
    Full Title: A Randomized, Double-Blind Comparison of LY2216684 and Placebo and Long Term Treatment with LY2216684 in Adult Patients with Major Depressive Disorder
    Medical condition: Patients with Major Depressive Disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision® (DSM-IV-TR; APA 2004),
    Disease: Version SOC Term Classification Code Term Level
    9.1 10025453 Major depressive disorder NOS LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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