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Clinical trials for Hyperaminoacidemia

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    3 result(s) found for: Hyperaminoacidemia. Displaying page 1 of 1.
    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: 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: 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
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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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