- Trials with a EudraCT protocol (397)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (65)
397 result(s) found for: Urea.
Displaying page 1 of 20.
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) | |||||||||||||
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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) | |||||||||||||
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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: | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-000075-27 | Sponsor Protocol Number: HPN-100-021 | Start Date*: 2016-03-07 | |||||||||||
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) | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) AT (Completed) IT (Completed) ES (Completed) | |||||||||||||
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... | |||||||||||||
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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 | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Completed) | |||||||||||||
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 (Trial now transitioned) | ||
Trial results: (No results available) |
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 | |||||||||||||
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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: 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 | |||||||||||||
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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... | ||||||||||||||||||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |||||||||||||||||||||||||||
Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) BG (Trial now transitioned) PL (Trial now transitioned) | ||||||||||||||||||||||||||||
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... | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Completed) 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... | |||||||||||||
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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 | |||||||||||||
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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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