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Clinical trials for Amino acid synthesis

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   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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    4 result(s) found for: Amino acid synthesis. Displaying page 1 of 1.
    EudraCT Number: 2007-001378-97 Sponsor Protocol Number: Ped3CB/P01/06/Mu.B Start Date*: 2007-08-14
    Sponsor Name:Baxter SAS
    Full Title: Safety during use of paediatric triple chamber bag formulas administered IV at a weight dependant dose during 5 consecutive days in paediatric patients up to 18 years requiring parenteral nutrition...
    Medical condition: The study is not focussed on a particular pathology but rather on the use of triple chamber bags in paediatrics, in any pathology requiring parenteral nutrition
    Disease: Version SOC Term Classification Code Term Level
    9.1 10051284 Parenteral nutrition PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-006968-11 Sponsor Protocol Number: AP214-CS005 Start Date*: 2009-04-21
    Sponsor Name:Action Pharma A/S
    Full Title: Pharmacokinectics of AP214 Acetate in patients undergoing cardiac surgery. A randomized, double-blind, placebo-controlled sequential ascending dose trial investigating pharmacokinetics, as well as...
    Medical condition: Action Pharma A/S is developing AP214 Acetate for the prevention of postsurgical kidney injury after thoracic aortic aneurysm repair surgery. In phase 2: Patients undergoing cardiac surgery, defin...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056675 Postoperative renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022630-92 Sponsor Protocol Number: AP214-CS007 Start Date*: 2010-11-05
    Sponsor Name:Action Pharma A/S
    Full Title: An Explorative Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Su...
    Medical condition: Action Pharma is developing AP214 Acetate for the prevention of postsurgical kidney injury after cardiac surgery. Trial population is patients with increased risk for development of Kidney Inju...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10022117 - Injury, poisoning and procedural complications 10056675 Postoperative renal failure PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    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
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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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