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Clinical trials for primary sclerosing cholangitis

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   44148   clinical trials with a EudraCT protocol, of which   7326   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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    14 result(s) found for: primary sclerosing cholangitis. Displaying page 1 of 1.
    EudraCT Number: 2019-000204-14 Sponsor Protocol Number: GS-US-428-4194 Start Date*: 2019-09-11
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) BE (Completed) AT (Completed) GB (GB - no longer in EU/EEA) DK (Prematurely Ended) FR (Completed) ES (Restarted) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002945-39 Sponsor Protocol Number: CM-101-PSC-101 Start Date*: 2020-04-15
    Sponsor Name:ChemomAb Ltd
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003367-19 Sponsor Protocol Number: NUC-5/PSC Start Date*: 2017-09-28
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
    Medical condition: Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and ...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Ongoing) GB (GB - no longer in EU/EEA) HU (Ongoing) LT (Ongoing) FI (Ongoing) CZ (Prematurely Ended) BE (Completed) DK (Ongoing) NL (Ongoing) FR (Ongoing) SE (Ongoing) NO (Ongoing) PL (Not Authorised) IE (Prematurely Ended) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003027-41 Sponsor Protocol Number: VLX-301 Start Date*: 2021-11-17
    Sponsor Name:Mirum Pharmaceuticals, Inc.
    Full Title: A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
    Medical condition: Pruritus associated with Primary Sclerosing Cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000875-37 Sponsor Protocol Number: VanC-IT Start Date*: 2022-11-03
    Sponsor Name:UNIVERSITÀ DEGLI STUDI MILANO BICOCCA
    Full Title: A Prospective, Randomized, Placebo-controlled Clinical Trial of oral vancomycin in adults and young adults (15-17 years old) affected by Primary Sclerosing Cholangitis with or without Inflammatory ...
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002695-37 Sponsor Protocol Number: CLIN-60190-453 Start Date*: 2023-04-27
    Sponsor Name:Ipsen Bioscience, Inc.
    Full Title: A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants with Primary ...
    Medical condition: Adults patients with Primary Sclerosing Cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001428-33 Sponsor Protocol Number: PLN-74809-PSC-203 Start Date*: 2020-11-05
    Sponsor Name:Pliant Therapeutics, Inc
    Full Title: A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis ...
    Medical condition: Primary sclerosing cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Completed) DE (Completed) BE (Completed) FR (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-018034-11 Sponsor Protocol Number: 2010vanco.psc Start Date*: 2013-04-29
    Sponsor Name:Karolinska Institutet
    Full Title: Open pilot study of treatment with vancomycin to children and adolescents with primary sclerosing cholangitis
    Medical condition: Primary Sclerosing Cholangitis (PSC) is a progressive disease of the biliary system which might lead to increased risk of cholangiocancer. PSC constitutes a common indication for adult liver transp...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001438-27 Sponsor Protocol Number: 48885 Start Date*: 2015-08-19
    Sponsor Name:Academic Medical Center
    Full Title: The effect of bezafibrate on cholestatic itch
    Medical condition: Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002526-25 Sponsor Protocol Number: EP-547-201 Start Date*: 2023-02-22
    Sponsor Name:Escient Pharmaceuticals, Inc.
    Full Title: Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
    Medical condition: Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    24.1 10040785 - Skin and subcutaneous tissue disorders 10064190 Cholestatic pruritus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004983-37 Sponsor Protocol Number: FFIS-INM-2017-04 Start Date*: 2018-10-16
    Sponsor Name:Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
    Full Title: Multicenter, randomized, prospective study to establish the clinical efficacy and the mechanisms of tolerance following immunosuppression withdrawal in liver transplantation
    Medical condition: Hepatic transplant
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002537-41 Sponsor Protocol Number: 20170104 Start Date*: 2022-01-06
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Sev...
    Medical condition: Moderate to Severe Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing) DK (Trial now transitioned) NL (Ongoing) DE (Trial now transitioned) HU (Trial now transitioned) FI (Trial now transitioned) BG (Trial now transitioned) IT (Ongoing) GR (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) RO (Trial now transitioned) SK (Trial now transitioned) LV (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004730-42 Sponsor Protocol Number: IQVIA-ODYS-001-LZA45541 Start Date*: 2022-10-24
    Sponsor Name:IQVIA RDS FRANCE SAS
    Full Title: Prospective evaluation of potential effects of repeated gadolinium-based contrast agent (GBCA) administrations of the same GBCA on motor and cognitive functions in neurologically normal adults in c...
    Medical condition: Long term potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among ne...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070999 Intraductal papillary mucinous neoplasm PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.1 100000004871 10008953 Chronic liver disease LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) IT (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003278-28 Sponsor Protocol Number: 204869 Start Date*: 2019-04-29
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an ...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Prematurely Ended) CZ (Prematurely Ended) FR (Prematurely Ended) BG (Prematurely Ended) PL (Prematurely Ended) NL (Prematurely Ended) BE (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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