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Clinical trials for Hyperammonemia

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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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

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    22 result(s) found for: Hyperammonemia. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-000787-16 Sponsor Protocol Number: C07-22 Start Date*: 2008-06-12
    Sponsor Name:Inserm
    Full Title: Etude pilote ouverte de l'effet de la fluoxetine chez des patientes agées de 8 à 28 ans atteintes du Syndrôme de Rett Typique
    Medical condition: Sydrome de Rett typique
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039000 Rett's disorder LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    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: 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 (Not Authorised) ES (Ongoing) DE (Ongoing) PT (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004345-32 Sponsor Protocol Number: ANAVEX2-73-RS-002 Start Date*: 2020-05-26
    Sponsor Name:Anavex Germany GmbH
    Full Title: A Double-Blind, Randomised, Placebo-Controlled, Safety and Efficacy Study of ANAVEX2-73 in Patients with Rett Syndrome
    Medical condition: Rett Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-003370-27 Sponsor Protocol Number: GWND18064 Start Date*: 2019-04-09
    Sponsor Name:GW Research Ltd
    Full Title: A randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of cannabidiol oral solution (GWP42003-P; CBD-OS) in patients with Rett syndrome.
    Medical condition: Rett syndrome (RTT) [typical or atypical]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001605-24 Sponsor Protocol Number: GWND19002 Start Date*: 2020-01-15
    Sponsor Name:GW Research Ltd
    Full Title: An open-label extension trial to investigate the long-term safety of cannabidiol oral solution (GWP42003-P, CBD-OS) in patients with Rett Syndrome
    Medical condition: Rett syndrome (RTT) [typical or atypical]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10077709 Rett syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) IT (Ongoing)
    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: 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 (Ongoing)
    Trial results: View results
    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: 2009-012602-39 Sponsor Protocol Number: 05-NEOV-002 Start Date*: 2010-05-17
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study evaluating the safety, tolerability, protein accretion, amino acid plasma levels and long-term outcome of Neoven compared to Vaminolact(R) in premature very low bir...
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of parenteral nutrition for premature ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10051284 Parenteral nutrition LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004448-20 Sponsor Protocol Number: Sarizotan/001/II/2015 Start Date*: 2016-11-28
    Sponsor Name:Newron Pharmaceuticals S.p.A.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Six-Month Study to Evaluate the Efficacy, Safety and Tolerability of Sarizotan in Patients with Rett Syndrome with Respiratory Symptoms
    Medical condition: Rett syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10039000 Rett's disorder LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2009-012604-92 Sponsor Protocol Number: 05-NEOV-004 Start Date*: 2010-04-19
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study of the safety and efficacy of Neoven compared to Vaminolact in infants and children requiring long-term parenteral nutrition
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of Parenteral Nutrition for infants an...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10051284 Parenteral nutrition LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003163-67 Sponsor Protocol Number: CAEB1102-102A Start Date*: 2019-01-15
    Sponsor Name:Aeglea Biotherapeutics, Inc.
    Full Title: An Open-label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of AEB1102 in Patients with Arginase I Deficiency
    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 (GB - no longer in EU/EEA) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-012603-26 Sponsor Protocol Number: 05-NEOV-003 Start Date*: 2010-04-08
    Sponsor Name:Fresenius Kabi Deutschland GmbH [...]
    1. Fresenius Kabi Deutschland GmbH
    2. Fresenius Kabi Deutschland GmbH
    Full Title: A randomised, double-blind study evaluating the safety, tolerability and clinical outcome of Neoven compared to Vaminolact in premature ELBW infants
    Medical condition: The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of Parenteral Nutrition for premature ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10051284 Parenteral nutrition LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) DE (Prematurely Ended) FR (Prematurely Ended)
    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 (Ongoing) ES (Ongoing) SE (Restarted) IT (Ongoing)
    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 (Ongoing) FR (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: 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: 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
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