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Clinical trials for Urea

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   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).

    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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    394 result(s) found for: Urea. Displaying page 1 of 20.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    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: 2008-003865-23 Sponsor Protocol Number: HPN-100-004 Start Date*: 2008-09-08
    Sponsor Name:Hyperion Therapeutics Limited
    Full Title: A Phase 2, Switch-Over, Dose-Escalation Study of the Safety and Tolerability of HPN-100 (glyceryl tri-[4-phenylbutyrate]) Compared to Sodium Phenylbutyrate in Adult and Pediatric Subjects with Urea...
    Medical condition: Urea Cycle Disorder (urea cycle enzyme or transporter deficiency)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    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: 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: 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: 2015-000075-27 Sponsor Protocol Number: HPN-100-021 Start Date*: 2017-05-04
    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
    20.1 200000003094 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Ongoing) GB (Completed) AT (Completed) IT (Completed) ES (Ongoing)
    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: 2020-001084-83 Sponsor Protocol Number: 38RC19.189 Start Date*: 2020-09-25
    Sponsor Name:CHU Grenoble-Alpes
    Full Title: Urea treatment of hyponatremia during subarachnoid hemorrhage
    Medical condition: Hyponatremia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003247-36 Sponsor Protocol Number: HPN-100-005SE Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN 100 Compared to Sodium Phenylbutyrate in Children 6–17 Years of Age with Urea Cycle Disorders, with a ...
    Medical condition: Urea Cycle Disorders
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003248-12 Sponsor Protocol Number: HPN-100-012SO Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment with HPN-100, in Pediatric Subjects under 6 Years of Age with Urea Cycle Di...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003249-82 Sponsor Protocol Number: HPN-100-012SE Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment with HPN-100, in Pediatric Subjects under 6 Years of Age with Urea Cycle Di...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001598-33 Sponsor Protocol Number: PSC-DS-BRETEX Start Date*: 2016-07-27
    Sponsor Name:SOFAR S.P.A.
    Full Title: Comparison of two methods for in vivo diagnosis of Helicobacter pylori infection, by means of a tablet of 13C-Urea.
    Medical condition: H. pylori infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10019377 Helicobacter pylori infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003989-27 Sponsor Protocol Number: PROLONGSTEM Start Date*: Information not available in EudraCT
    Sponsor Name:Promethera Therapeutics
    Full Title: PROLONGSTEM: HepaStem Long-Term Safety Registry Registry for patients who have been administered HepaStem
    Medical condition: This study will include all patients having received at least one infusion of the Investigational Medicinal Product (IMP) HepaStem HALPC during a previous interventional clinical study conducted by...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10021601 Inborn error of metabolism NOS LLT
    20.0 100000004871 10008954 Chronic liver disease and cirrhosis LLT
    20.1 100000004871 10049844 Acute liver failure LLT
    21.1 200000003094 10013373 Disorders of urea cycle metabolism LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Ongoing) ES (Ongoing) GB (GB - no longer in EU/EEA) BG (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000824-36 Sponsor Protocol Number: HLSC-UCD-01 Start Date*: 2021-12-09
    Sponsor Name:Unicyte AG
    Full Title: An open-label, controlled, multi-site, Phase I clinical trial to assess the ureagenesis capacity in newborns and infants up to the age of 12 months with neonatal and infantile onset of urea cycle d...
    Medical condition: Subject has a genetically confirmed diagnosis of any of the following urea cycle disorders: ASS, CPS1, ASL, OTC Subjects without UCD can have other stable illness that not interfere with the clini...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10080020 Urea cycle disorder PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) AT (Prematurely Ended) IT (Prematurely Ended) BE (Completed) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003246-26 Sponsor Protocol Number: HPN-100-005SO Start Date*: 2015-02-10
    Sponsor Name:Hyperion Therapeutics, Inc.
    Full Title: A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN 100 Compared to Sodium Phenylbutyrate in Children 6–17 Years of Age with Urea Cycle Disorders, with a ...
    Medical condition: Urea Cycle Disorders (UCDs)
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2011-004074-28 Sponsor Protocol Number: UKHEP001 Start Date*: 2012-07-20
    Sponsor Name:Promethera Biosciences
    Full Title: A prospective, open label, multicenter, randomized, safety and preliminary efficacy study of one cycle of Promethera HepaStem® in Urea Cycle Disorders and Crigler-Najjar Syndrome patients
    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
    17.0 100000004850 10021601 Inborn error of metabolism NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004842-40 Sponsor Protocol Number: K020-218 Start Date*: 2019-08-21
    Sponsor Name:Kaleido Biosciences
    Full Title: A Phase 2, Open-label Study to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
    Medical condition: Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10080020 Urea cycle disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) ES (Prematurely Ended) FR (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-005416-26 Sponsor Protocol Number: ANSWER Start Date*: 2014-06-06
    Sponsor Name:Mario Negri Institute
    Full Title: A Prospective, Randomized, Open, Blinded Endpoint (PROBE), Clinical Trial to Assess The Renal and Humoral Effects of Sevelamer Carbonate in Patients with Chronic Kidney Disease and Residual Protein...
    Medical condition: Chronic Kidney Disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002481-78 Sponsor Protocol Number: EBI-EA230-LPS-2014 Start Date*: 2014-10-07
    Sponsor Name:Exponential Biotherapies Inc
    Full Title: Randomized double blind placebo-controlled clinical safety, tolerability and pharmacokinetic/-dynamic study on the effects of escalating single intravenous doses of EA-230 on the innate immune resp...
    Medical condition: Systemic inflammatory respons (SIRS) and associated acute kidney injury (AKI)
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
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