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Clinical trials for Ornithine

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44335   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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    34 result(s) found for: Ornithine. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-003384-25 Sponsor Protocol Number: DTX301-CL301 Start Date*: 2022-12-16
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Adeno-Associated Virus Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Patients with Late-Onset...
    Medical condition: Late-onset Ornithine transcarbamylase (OTC) deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10071107 Ornithine transcarbamylase deficiency LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000156-18 Sponsor Protocol Number: 301OTC02 Start Date*: 2018-08-15
    Sponsor Name:Ultragenyx Pharmaceutical, Inc.
    Full Title: A Long-Term Follow-up Study to Evaluate the Safety and Efficacy of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Lat...
    Medical condition: Ornithine transcarbamylase deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10071107 Ornithine transcarbamylase deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001057-40 Sponsor Protocol Number: 301OTC01 Start Date*: 2017-03-14
    Sponsor Name:Ultragenyx Pharmaceutical, Inc.
    Full Title: A Phase 1/2, Open-Label Safety and Dose-Finding Study of Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC) in Adults with Late-Onset OT...
    Medical condition: Ornithine transcarbamylase deficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10071107 Ornithine transcarbamylase deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (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: 2012-002120-33 Sponsor Protocol Number: HLSCS01-11 Start Date*: 2013-12-06
    Sponsor Name:AZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA
    Full Title: Human Liver Stem Cells (HLSCs) in patients suffering from liver-based inborn metabolic diseases causing life-threatening neonatal onset of hyperammonemic encephalopathy
    Medical condition: neonatal hyperammonemic encephalopathy associated with inborn liver metabolic diseases
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10059521 Methylmalonic aciduria PT
    14.1 10010331 - Congenital, familial and genetic disorders 10058299 Argininosuccinate lyase deficiency PT
    14.1 10010331 - Congenital, familial and genetic disorders 10052450 Ornithine transcarbamoylase deficiency PT
    14.1 10010331 - Congenital, familial and genetic disorders 10058297 Carbamoyl phosphate synthetase deficiency PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003817-32 Sponsor Protocol Number: LOLA-Merz:WMDHP39937 Start Date*: 2013-01-08
    Sponsor Name:Imperial College London
    Full Title: Brain muscle axis during treatment of hepatic encephalopathy with L-ornithine L-aspartate
    Medical condition: Hepatic Encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10019660 Hepatic encephalopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2013-005412-10 Sponsor Protocol Number: OCR002-HE209 Start Date*: 2014-08-25
    Sponsor Name:Ocera Therapeutics Inc
    Full Title: Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemi...
    Medical condition: Hepatic encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029205 - Nervous system disorders 10019660 Hepatic encephalopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) CZ (Completed) AT (Completed) HU (Completed) IT (Completed) DE (Completed) NL (Completed) BE (Completed) DK (Completed) BG (Completed)
    Trial results: View results
    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: 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: 2004-000726-78 Sponsor Protocol Number: SPD488-401 Start Date*: 2004-12-02
    Sponsor Name:Shire Pharmaceuticals Group plc
    Full Title: A 24 Week Randomised Double Blind Placebo Controlled Study to Evaluate the Atrophogenic Potential of Eflornithine in the Treatment of Women with Excessive Facial Hair
    Medical condition: Facial Hirsutism in Women
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-000988-14 Sponsor Protocol Number: CCD05 Start Date*: 2016-10-12
    Sponsor Name:PROMETHERA Biosciences S.A./N.V.
    Full Title: Title: Open, Prospective, Historic-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Infusion of Liver Cell Suspension (HHLivC) in Children with Urea Cycle Disorders
    Medical condition: Neonatal-onset type of the following urea cycle disorders (UCD): ornithine transcarbamylase deficiency (OTCD), carbamoylphosphate synthetase I deficiency (CPS1D), or argininosuccinate synthetas...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-001034-14 Sponsor Protocol Number: 07/Q0803/31 Start Date*: 2007-08-10
    Sponsor Name:St George's Healthcare NHS Trust [...]
    1. St George's Healthcare NHS Trust
    2. SLA Pharma
    Full Title: The effect of omega-3 fatty acids on Barrett's oesophagus
    Medical condition: Barrett's oesophagus refers to changes in the lining of the lower oesophagus in response to injury caused by gastric reflux. It is a pre-malignant condition and has a well established link with ad...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004134 Barrett's esophagus LLT
    9.1 10004136 Barrett's oesophagitis with dysplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000330-35 Sponsor Protocol Number: HS-2012-1 Start Date*: 2013-05-23
    Sponsor Name:Medizinische Universität Graz
    Full Title: Effects of Linagliptin on endothelial function and global arginine bioavailability ratio in coronary artery disease patients with early diabetes
    Medical condition: Diabetes mellitus Type 2
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002924-11 Sponsor Protocol Number: LOLAbiome Start Date*: 2023-01-09
    Sponsor Name:CBmed GmbH
    Full Title: An observational study on the effect of L-ornithine-L-aspertate (LOLA) on the Flavonifractor abundance in the gut microbiome in liver cirrhosis
    Medical condition: Liver cirrhosis with covert or overt hepatic encephalopathy (grade 0-2)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10024667 Liver cirrhosis LLT
    20.0 100000004852 10014630 Encephalopathy hepatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003851-45 Sponsor Protocol Number: CAEB1102-101A Start Date*: 2018-03-14
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: A Phase 1/2 Open-label Study in Patients with Arginase I Deficiency to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous AEB1102
    Medical condition: Arginase 1 deficiency Hyperargininemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10062695 Arginase deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014437-24 Sponsor Protocol Number: P090203 Start Date*: 2009-09-23
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Essai randomisé d'immunonutrition par L-arginine guidée en réanimation non chirurgicale
    Medical condition: Patients de réanimation non chirurgicale sous ventilation artificielle, non immunodéprimés
    Disease: Version SOC Term Classification Code Term Level
    8.1 10062733 Nutritional supplement PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-018695-25 Sponsor Protocol Number: Anidulafungine/péritonite Start Date*: 2010-05-08
    Sponsor Name:ADRFARCP
    Full Title: Etude prospective de la prescripion d'anidulafungine pour infections intra-abdominales graves hospitalisées en réanimation
    Medical condition: patients hospitalisés en unité de réanimation pour infection intra-abdominale grave à levures
    Disease: Version SOC Term Classification Code Term Level
    12.1 10056570 Intra-abdominal infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000933-18 Sponsor Protocol Number: HLSC-UCD-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Unicyte AG
    Full Title: An Open-label, Non-controlled, Multi-center, Phase 2 Study to Assess the Efficacy and Safety of Allogeneic Human Liver Stem Cells (HLSCs) in the Treatment of Pediatric Patients with Early-onset Ure...
    Medical condition: Urea cycle disorders
    Disease: Version SOC Term Classification Code Term Level
    21.1 200000003094 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005278-11 Sponsor Protocol Number: A8851022 Start Date*: 2009-03-06
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: EFFICACY AND SAFETY OF ERAXIS™/ECALTA® (ANIDULAFUNGIN) COMPARED TO CANCIDAS® (CASPOFUNGIN) IN PATIENTS WITH CANDIDA DEEP TISSUE INFECTION
    Medical condition: INVASIVE CANDIDIA INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064954 Invasive candidiasis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) BE (Prematurely Ended) IE (Prematurely Ended) NL (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
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