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Clinical trials for Bilirubin Metabolism

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).

    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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    125 result(s) found for: Bilirubin Metabolism. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2009-017026-39 Sponsor Protocol Number: UCBT-002 Start Date*: 2009-12-28
    Sponsor Name:Aldagen, Inc
    Full Title: A PHASE III TRIAL OF ALD-101 ADUVANT THERAPY of UNRELATED UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT) IN PATIENTS WITH INBORN ERRORS OF METABOLISM
    Medical condition: Inborn errors of metabolism
    Disease: Version SOC Term Classification Code Term Level
    9.1 10062018 Inborn error of metabolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-011921-15 Sponsor Protocol Number: UCBT-002 Start Date*: 2009-06-22
    Sponsor Name:Aldagen, Inc
    Full Title: A PHASE III TRIAL OF ALD-101 ADUVANT THERAPY of UNRELATED UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT) IN PATIENTS WITH INBORN ERRORS OF METABOLISM
    Medical condition: Inborn errors of metabolism
    Disease: Version SOC Term Classification Code Term Level
    9.1 10062018 Inborn error of metabolism LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Not Authorised)
    Trial results: (No results available)
    EudraCT Number: 2013-001045-14 Sponsor Protocol Number: SAF001 Start Date*: 2013-04-22
    Sponsor Name:Promethera Biosciences
    Full Title: SAF 001: A long-term safety follow-up study of patients suffering from Urea Cycle disorders (UCD) or Crigler-Najjar Syndrome (CN) having received infusions of HepaStem.
    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
    15.1 100000004850 10021601 Inborn error of metabolism NOS LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) PT (Completed) IT (Completed) GB (Completed)
    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: 2011-004259-38 Sponsor Protocol Number: CAC-91-10-10 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: Investigation in the Pathogenesis of Liver Disease in Patients with Inborn Errors of bile Acid Metabolism
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2004-002418-12 Sponsor Protocol Number: CFEM345D2407 Start Date*: 2005-01-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, randomized, multicenter safety study to evaluate the skeletal and lipid profile effects of letrozole and tamoxifen in postmenopausal women with resected, receptor positive early brea...
    Medical condition: Bone loss attributed to cessation of ovarian estrogen production is common in postmenopausal women. In postmenopausal women with breast cancer, treatment with an aromatase inhibitor may further red...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-002054-39 Sponsor Protocol Number: ODX-002 Start Date*: 2014-11-10
    Sponsor Name:DexTech Medical AB
    Full Title: A randomized, double-blind, placebo-controlled multi-centre phase II study to evaluate efficacy and tolerability of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
    Medical condition: Metastatic Castration Resistant Prostate Cancer (CRPC)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001559-20 Sponsor Protocol Number: 95195608 Start Date*: 2007-04-17
    Sponsor Name:Cliniques Universitaires Saint-Luc
    Full Title: Steady-state pharmacokinetics of high dose acetaminophen inpost-op children. Rational use of N-acetyl cysteine for prevention of liver toxicity related to cumulative doses.
    Medical condition: Major surgery when the use of paracetamol is required for pain release
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001055-50 Sponsor Protocol Number: EP-001 Start Date*: 2016-08-08
    Sponsor Name:Empros Pharma AB
    Full Title: A, single center, controlled, multiple dose, randomized study during two weeks, investigating the effect of the test formulation on efficacy, safety and markers for appetite regulation, glucose and...
    Medical condition: Obesity and diabetes, type 2.
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2015-005666-37 Sponsor Protocol Number: ODX-003 Start Date*: 2016-02-26
    Sponsor Name:DexTech Medical AB
    Full Title: A randomized, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases
    Medical condition: Metastatic Castration Resistant Prostate Cancer (CRPC) and skeletal metastases
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) EE (Completed) LV (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004528-36 Sponsor Protocol Number: CAC-002-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An open-label, single center, non-randomized, continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis.
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2005-005843-24 Sponsor Protocol Number: RIFA+UDCA Start Date*: 2006-02-23
    Sponsor Name:Hanns-Ulrich Marschall
    Full Title: Studie på effekten av rifampicin och ursodeoxycholsyra på gallipider och deras transport och avgiftning hos patienter med kolesterolgallstenar.
    Medical condition: Gallstone disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003093-13 Sponsor Protocol Number: BREAKFAST Start Date*: 2020-01-14
    Sponsor Name:FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    Full Title: Targeting triple negative BREAst cancer metabolism with a combination of chemotherapy and a diet mimicking FASTing plus/minus metformin in the preoperative setting: the BREAKFAST trial
    Medical condition: Targeting triple negative BREAst cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10025541 Malignant breast neoplasm LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-006906-41 Sponsor Protocol Number: TAK-475_310 Start Date*: Information not available in EudraCT
    Sponsor Name:Takeda Global Research & Development Centre (Europe) Ltd
    Full Title: A Modified Case Control Study To Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure To Lapaquistat Acetate
    Medical condition: A Modified Case Control Study To Identify Pharmacogenomic Factors Associated With Hepatocellular Injury Following Exposure To Lapaquistat Acetate
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FI (Completed) LV (Completed) CZ (Completed) NL (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2012-002499-15 Sponsor Protocol Number: A536-04 Start Date*: 2012-12-19
    Sponsor Name:ACCELERON PHARMA INC
    Full Title: A Phase 2, Open-Label, Ascending Dose Study to Evaluate the Effects of ACE-536 in Patients with β-Thalassemia Intermedia
    Medical condition: β-thalassemia intermedia
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004850 10062923 Thalassemia intermedia LLT
    15.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004882-26 Sponsor Protocol Number: ND-L02-s0201-002 Start Date*: 2015-03-25
    Sponsor Name:Nitto Denko Corporation
    Full Title: A Phase 1b/2, Open Label, Randomized, Repeat Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Biological Activity and Pharmacokinetics of ND L02 s0201 Injection, a Vitamin A-couple...
    Medical condition: Moderate to extensive progressive hepatic fibrosis (METAVIR F3-4)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10019805 - Hepatobiliary disorders 10019668 Hepatic fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2013-004323-37 Sponsor Protocol Number: BOS-IIG-01 Start Date*: 2015-03-24
    Sponsor Name:Fundación PETHEMA para el tratamiento de la leucemia y el linfoma
    Full Title: Single nucleotide polymorphism association with response and toxic effects in patients with Ph+ CP-CML treated with bosutinib after relapse or intolerance to previous treatment.
    Medical condition: Patients with chromosome Philadelphia positive (Ph+) in chronic phase mielogenus leukemia (CP CML)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10022891 - Investigations 10034877 Philadelphia chromosome positive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004126-56 Sponsor Protocol Number: NUTH-2005-03523 Start Date*: 2006-03-07
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Trust
    Full Title: Observational pharmacokinetic study of doxorubicin and cyclophosphamide in patients with early breast cancer.
    Medical condition: Early breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2006-001972-19 Sponsor Protocol Number: Feno Atorva Start Date*: 2007-01-22
    Sponsor Name:Hanns-Ulrich Marschall
    Full Title: Study of atorvastatin and fenofibrate mediated effects on the metabolism and hepatic excretion of biliary compounds in gallstone patients.
    Medical condition: Gallstone disease
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020667 Hyperlipidemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004044-28 Sponsor Protocol Number: AKF-396 Start Date*: 2020-12-18
    Sponsor Name:University of Southern Denmark
    Full Title: Flucloxacillin as an inducer of CYP-enzymes
    Medical condition: Healthy volunteers. (Flucloxacillin is used against infections caused by beta-lactamase-producing organisms) Testing for drug-drug interactions caused by flucloxacillin
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10004035 Bacterial infection due to staphylococcus aureus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (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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