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Clinical trials for PSC

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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    265 result(s) found for: PSC. Displaying page 1 of 14.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    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: 2014-005558-21 Sponsor Protocol Number: LUM001-401 Start Date*: 2015-03-25
    Sponsor Name:Lumena Pharmaceuticals LLC
    Full Title: A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Primary Sclerosing Cholan...
    Medical condition: Primary sclerosing cholangitis (PSC) is a chronic cholestatic liver disease of unknown aetiology. PSC is characterized by inflammation and fibrosis of the intra- and extrahepatic biliary tree re...
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-002393-37 Sponsor Protocol Number: RG_13-027 Start Date*: 2015-01-06
    Sponsor Name:University of Birmingham
    Full Title: A single arm, two-stage, multi-centre, phase II clinical trial investigating the safety and activity of the use of BTT1023, a human monoclonal antibody targeting vascular adhesion protein (VAP-1), ...
    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 (Completed)
    Trial results: View results
    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: 2015-003310-24 Sponsor Protocol Number: UDCAPSCSURV Start Date*: 2015-10-09
    Sponsor Name:Sahlgrenska Academy
    Full Title: A Phase 3, Open-label, Randomized, Prospective Clinical Trial Evaluating the Efficacy of Stratified Treatment with Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy ...
    Medical condition: Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002754-31 Sponsor Protocol Number: NUC-3/PSC Start Date*: 2012-08-02
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
    Medical condition: primary sclerosing cholangitis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) NL (Completed) LT (Completed) NO (Completed) SE (Completed) GB (Completed) ES (Completed) FI (Completed) HU (Completed) DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002473-61 Sponsor Protocol Number: GS-US-321-0102 Start Date*: 2013-05-08
    Sponsor Name:Gilead Sciences Inc
    Full Title: A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects wi...
    Medical condition: Primary Sclerosing Cholangitis (PSC)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004871 10036732 Primary sclerosing cholangitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) SE (Completed) IT (Completed) DK (Completed) ES (Completed) BE (Completed) NL (Completed)
    Trial results: View results
    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: 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 (Trial now transitioned) AT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) LT (Completed) FI (Trial now transitioned) CZ (Prematurely Ended) BE (Completed) DK (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) SE (Completed) NO (Trial now transitioned) PL (Trial now transitioned) IE (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-007837-38 Sponsor Protocol Number: 111414 Start Date*: 2008-05-20
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, randomized, controlled, primary vaccination study to demonstrate non-inferiority of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY conjugate vaccine compared to ...
    Medical condition: Single dose primary immunization against Neisseria meningitidis (N. meningitidis) serogroups A, C, W-135, and Y in healthy subjects aged 2 through 10 years.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed)
    Trial results: View results
    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 (Trial now transitioned)
    Trial results: (No results available)
    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: 2014-003942-28 Sponsor Protocol Number: MLN0002-3023 Start Date*: 2016-05-29
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying...
    Medical condition: Primary Sclerosing Cholangitis (PSC) Inflammatory Bowel Disease (IBD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004871 10036732 Primary sclerosing cholangitis LLT
    19.0 10017947 - Gastrointestinal disorders 10021972 Inflammatory bowel disease PT
    19.0 10017947 - Gastrointestinal disorders 10021973 Inflammatory bowel disease NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Prematurely Ended) GB (Completed) HU (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) CZ (Completed) AT (Prematurely Ended) PL (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    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: View results
    EudraCT Number: 2019-001760-30 Sponsor Protocol Number: CB8025-21845 Start Date*: 2019-10-11
    Sponsor Name:CymaBay Therapeutics
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Prima...
    Medical condition: Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts ca...
    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 (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003392-30 Sponsor Protocol Number: 15-0106 Start Date*: 2016-04-18
    Sponsor Name:NGM Biopharmaceuticals, Inc.
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WIT...
    Medical condition: PRIMARY SCLEROSING CHOLANGITIS (PSC)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10019805 - Hepatobiliary disorders 10036732 Primary sclerosing cholangitis LLT
    19.0 10019805 - Hepatobiliary disorders 10004607 Bile duct infections and inflammations HLT
    19.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    19.0 10019805 - Hepatobiliary disorders 10008609 Cholangitis sclerosing PT
    19.0 10019805 - Hepatobiliary disorders 10004606 Bile duct disorders HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2018-004258-77 Sponsor Protocol Number: CM-101-PSC-001 Start Date*: 2019-02-05
    Sponsor Name:ChemomAb Ltd.
    Full Title: A Phase 2, Open Label, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of CM-101 Administered for 12 Weeks in Adult Subjects with Primary Sclerosing Cholangitis.
    Medical condition: Treatment of 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 (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-003824-51 Sponsor Protocol Number: 112036 Start Date*: 2009-08-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningoco...
    Medical condition: Healthy male and female children who completed the primary immunisation study MenACWY-TT-039 (109670) and were 12 to 23 months of age at the time of primary vaccination.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2016-002442-23 Sponsor Protocol Number: GS-US-428-4025 Start Date*: 2017-01-09
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis
    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 (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002205-38 Sponsor Protocol Number: 747-207 Start Date*: 2015-12-02
    Sponsor Name:INTERCEPT PHARMACEUTICALS INC.
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis
    Medical condition: Primary Sclerosing Cholangitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
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