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Clinical trials for Hepatotoxicity

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   44353   clinical trials with a EudraCT protocol, of which   7380   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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    39 result(s) found for: Hepatotoxicity. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-005015-17 Sponsor Protocol Number: GE09-01 Start Date*: 2009-05-13
    Sponsor Name:VU university medical centre
    Full Title: Effect of N-acetylcysteine on thiopurine related hepatotoxicity in IBD patients
    Medical condition: adult patients (18-70 years old) who have been treated with azathioprine, 6-mercaptopure or 6-thioguanine for inflammatory bowel disease, in whom hepatotoxicity occured as an adverse event, are eli...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015403-95 Sponsor Protocol Number: NS10364-3 Start Date*: 2010-02-11
    Sponsor Name:Faculty Hospital Hradec Králové
    Full Title: A pilot trial of noninvasive assessment of methotrexate hepatotoxicity in the course of pharmacokinetically guided pharmacotherapy of psoriasis with methotrexate and folic acid
    Medical condition: moderate-severe and severe plaque psoriasis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000572-15 Sponsor Protocol Number: EGF117268 Start Date*: 2013-07-01
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: Investigation of immune mechanisms relating to lapatinib associated hepatotoxicity: ex vivo T cell biology investigation relating to lapatinib induced liver adverse events using PBMCs from patie...
    Medical condition: The subjects participated in the EGF105485 study, a randomized, placebo-controlled study of lapatinib in HER2-positive early-stage breast cancer. During participation in this study, subjects had b...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004321-26 Sponsor Protocol Number: 1100.1452 Start Date*: 2006-02-17
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: A Case-Control Toxicogenomics Study to identify Unique Genetic Polymorphisms in Patients who have experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity within the First 8 weeks of Nev...
    Medical condition: The patient population for this study will be comprised of patients with HIV-1 infection who have taken or are currently taking nevirapine and who have (cases) or have not (controls) experienced sy...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002724-25 Sponsor Protocol Number: 08-2018-07-31 Start Date*: 2017-11-16
    Sponsor Name:Helle Holst
    Full Title: Intravenous and oral paracetamol in neonates: safety and ethanol-drug interactions – the PARASHUTE Trial
    Medical condition: Liver toxicity following prolonged administration of i.v. or oral paracetamol
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10019850 Hepatotoxic effect LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-002160-28 Sponsor Protocol Number: hepatology_MT_2005-05 Start Date*: 2005-09-23
    Sponsor Name:Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology
    Full Title: Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis
    Medical condition: Reduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essen...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-013456-76 Sponsor Protocol Number: roofthooft/paracetamol Start Date*: 2010-04-22
    Sponsor Name:
    Full Title: Pharmakokinetics and Pharmacodynamics of Acetaminophen( paracetamol i.v) in Neonates
    Medical condition: We want to determine the optimal loading dose of intravenous Acetaminophen in neonates of different gestational age subgroups. To this effect a loading dose of 10mg/kg, 15mg/kg or 20mg/kg Acetam...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015904-24 Sponsor Protocol Number: UKB-2009-MED-I-JKR-01 Start Date*: 2010-10-20
    Sponsor Name:Rheinische Friedrich-Wilhelms-Universität Bonn
    Full Title: An open, prospective study to compare the safety and efficacy of raltegravir vs. atazanavir / ritonavir, both in combination with tenofovir DF and emtricitabine, in the treatment of HIV-infection i...
    Medical condition: HIV disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-017148-15 Sponsor Protocol Number: CCOX189A2483 Start Date*: 2010-04-12
    Sponsor Name:NOVARTIS FARMA
    Full Title: A retrospective pharmacogenetic analysis of patients with elevated liver enzymes (Hy s law cases or AST/ALT > 10x ULN) in clinical studies CCOX189A0117, CCOX189A2332, CCOX189A2369, CCOX189A0126,...
    Medical condition: patients with elevated liver enzymes (Hy s law cases or AST/ALT > 10x ULN
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003409-33 Sponsor Protocol Number: AllopurinolALL3.1 Start Date*: 2016-12-09
    Sponsor Name:Västra Götaland Regionen
    Full Title: Optimizing 6-mercaptopurine therapy in pediatric acute lymphoblastic leukemia by using allopurinol. Clinical study in children 1-19 years on maintenance therapy for acute lymphoblastic leukemia.
    Medical condition: Acute lymphoblastic leukemia diagnosed at age 0-18 in children
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-000632-27 Sponsor Protocol Number: PORT-01 Start Date*: 2022-08-03
    Sponsor Name:Radboud University Medical Center
    Full Title: Pragmatic trial on the safety and tolerability of an optimized dose of rifampicin in tuberculosis patients
    Medical condition: Tuberculosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-017800-10 Sponsor Protocol Number: CZB/4/722 Start Date*: 2010-04-01
    Sponsor Name:NHS Lothian [...]
    1. NHS Lothian
    2. University of Edinburgh
    Full Title: Scottish and Newcastle Anti-emetic Pre-treatment for Paracetamol Poisoning study (SNAP)
    Medical condition: Paracetamol overdose
    Disease: Version SOC Term Classification Code Term Level
    2.2 10033295 Overdose LLT
    2.2 10033297 accidental overdose LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-001288-32 Sponsor Protocol Number: I3CPh1-FSM-01.11 Start Date*: 2011-04-18
    Sponsor Name:FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE
    Full Title: A Pilot Study to Evaluate the Safety and Tolerability of the combination ot Trabectidin and Indole-3-Carbinol in refractory ER-positive metastatic breast cancer
    Medical condition: Refractory ER-positive metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-001899-20 Sponsor Protocol Number: DAR-311-E Start Date*: 2007-01-16
    Sponsor Name:Gilead Sciences Inc.
    Full Title: DORADO-EX – A Dose-Blinded, Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension A Dose-Blinded, Long-Term Safety Extension Study...
    Medical condition: Resistant hypertension
    Disease: Version SOC Term Classification Code Term Level
    8.1 10038274 Refractory hypertension LLT
    Population Age: Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) SE (Prematurely Ended) FR (Completed) DE (Prematurely Ended) IT (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-023437-30 Sponsor Protocol Number: A7281006 Start Date*: 2011-09-29
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE(OPERA)
    Medical condition: Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    16.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BE (Completed) SE (Completed) AT (Completed) DE (Completed) PT (Prematurely Ended) NO (Completed) NL (Completed) ES (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2022-001656-41 Sponsor Protocol Number: TCeD21 Start Date*: 2022-12-07
    Sponsor Name:Topas Therapeutics GmbH
    Full Title: A double-blind, randomized, placebo-controlled, phase 2a study to evaluate the safety, tolerability, and pharmacodynamic (PD) effects of two infusions of escalating doses of TPM502 in adults diagno...
    Medical condition: Coeliac disease
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed) FI (Completed) DE (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002106-68 Sponsor Protocol Number: CTU/2020/354 Start Date*: 2020-07-16
    Sponsor Name:University College London Comprehensive Clinical Trial Unit
    Full Title: Favipiravir, lopinavir/ritonavir or combination therapy: a randomised, double blind, 2x2 factorial placebo-controlled trial of early antiviral therapy in COVID-19
    Medical condition: SARS-CoV-2 (Corona virus) infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10053983 Corona virus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2020-003413-35 Sponsor Protocol Number: WN42349 Start Date*: 2020-12-07
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, SINGLE ARM, OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF SATRALIZUMAB IN PATIENTS WITH NEUROMYELITIS OPTICA SPECTRUM DISORDER (NMOSD)
    Medical condition: Neuromyelitis Optic Spectrum Disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10077875 Neuromyelitis optica spectrum disorder PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) HU (Completed) BG (Completed) PL (Completed) IT (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2005-005023-33 Sponsor Protocol Number: 1182.99 Start Date*: 2007-03-15
    Sponsor Name:Boehringer Ingelheim France SAS
    Full Title: Safety and efficacy study of TPV boosted with low dose ritonavir (TPV/r) 500 mg/200 mg BID in antiretroviral treatment experienced HIV positive patients with HCV or HBV co-infection, with a pilot e...
    Medical condition: Treatment with three-class (NRTI, NNRTI, and PI) experienced HIV positive patients with HCV or HBV co-infection, with a minimum of 3-months duration for each class and have documented resistance to...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020192 HIV-1 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) PT (Prematurely Ended) ES (Completed) DE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001585-15 Sponsor Protocol Number: 2018-01671 Start Date*: 2020-01-30
    Sponsor Name:Centre Hospitalier Universitaire Vaudois
    Full Title: PTX3 genetically stratified randomized double-blinded allocation eventdriven clinical trial for antifungal prophylaxis in patients with acute myeloid leukemia
    Medical condition: Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome in transformation (MDSit) who receive antifungal profylaxis during their treatment with an intensive chemotherapy regimen, inc...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
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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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