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Clinical trials for Cholestatic pruritus

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    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).

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    21 result(s) found for: Cholestatic pruritus. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2021-002526-25 Sponsor Protocol Number: EP-547-201 Start Date*: 2022-11-30
    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: FR (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003158-10 Sponsor Protocol Number: 212358 Start Date*: 2020-06-04
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis
    Medical condition: Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10064190 Cholestatic pruritus PT
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004070-42 Sponsor Protocol Number: A4250PBCpruritus Start Date*: 2014-12-09
    Sponsor Name:Sahlgrenska Academy
    Full Title: An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic Pruritus
    Medical condition: Primary biliary cirrhosis complicated by cholestatic pruritus.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000007-21 Sponsor Protocol Number: 212620 Start Date*: 2021-08-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants wit...
    Medical condition: Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC).
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10064190 Cholestatic pruritus PT
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed) IT (Completed) CZ (Completed) GR (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001157-32 Sponsor Protocol Number: A4250-003 Start Date*: 2015-05-13
    Sponsor Name:Albireo AB
    Full Title: An exploratory Phase II Study to demonstrate the Safety and Efficacy of A4250 in Children with Cholestatic Pruritus
    Medical condition: Patients wih Cholestatic Pruritus
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-001389-39 Sponsor Protocol Number: VLX-601 Start Date*: 2022-04-19
    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 Biliary Cholangitis (VANTAGE)
    Medical condition: Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-005346-38 Sponsor Protocol Number: LUM001-302 Start Date*: 2013-06-11
    Sponsor Name:Lumena Pharmaceuticals, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN THE TREATMENT OF CHOLESTAT...
    Medical condition: Alagille syndrome (ALGS). This is an example of cholestatic liver disease in children. In patients with Alagille syndrome, impairment of the egress of bile acids from the liver leads to cholestasi...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Children, Adolescents, Under 18 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: 2013-003832-54 Sponsor Protocol Number: LUM001-303 Start Date*: 2013-11-28
    Sponsor Name:Mirum Pharmaceuticals, Inc.
    Full Title: A MULTICENTRE EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND DURABILITY OF THE THERAPEUTIC EFFECT OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTI), IN THE TREATME...
    Medical condition: Alagille syndrome (ALGS). This is an example of cholestatic liver disease in children. In patients with Alagille syndrome, impairment of the egress of bile acids from the liver leads to cholestasis...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002755-42 Sponsor Protocol Number: MRX-800 Start Date*: 2020-03-16
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: MRX-800: A Long-Term Safety Study of Maralixibat, an Apical Sodium Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Partic...
    Medical condition: Long-term safety study with Maralixibat, in treatment of subjects with cholestatic liver disease including, but not limited to, Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Choles...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    20.0 10010331 - Congenital, familial and genetic disorders 10004653 Biliary atresia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) GB (GB - no longer in EU/EEA) PL (Completed) FR (Completed) ES (Completed)
    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: 2013-003833-14 Sponsor Protocol Number: LUM001-501 Start Date*: 2014-01-30
    Sponsor Name:Mirum Pharmaceuticals, Inc.
    Full Title: OPEN LABEL STUDY OF THE EFFICACY AND LONG TERM SAFETY OF LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN THE TREATMENT OF CHOLESTATIC LIVER DISEASE IN PEDIATRIC PATIE...
    Medical condition: In patients with progressive familial intrahepatic cholestasis (PFIC), impairment of the egress of bile acids from the liver leads to cholestasis, hepatocellular injury and damage, and progressive ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-001211-22 Sponsor Protocol Number: MRX-502 Start Date*: 2019-10-29
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: MRX-502: Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis ...
    Medical condition: Progressive Familial Intrahepatic Cholestasis (PFIC) In patients with progressive familial intrahepatic cholestasis (PFIC), impairment of the egress of bile acids from the liver leads to cholestasi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) HU (Completed) PL (Completed) AT (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000906-20 Sponsor Protocol Number: LUM001-601 Start Date*: 2015-05-13
    Sponsor Name:Shire Human Genetic Therapies Inc
    Full Title: An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Alagille Syndrome (ALGS) ...
    Medical condition: Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    17.1 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000482-36 Sponsor Protocol Number: LUM001-201 Start Date*: 2013-07-08
    Sponsor Name:Lumena Pharmaceuticals, Inc.
    Full Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA)...
    Medical condition: Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead ...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-003395-39 Sponsor Protocol Number: MRX-503 Start Date*: 2020-02-14
    Sponsor Name:Mirum Pharmaceuticals Inc.
    Full Title: MRX-503: An Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Maralixibat in the Treatment of Subjects with Progressive Familial Intrahepatic Cholestasis (PFIC)
    Medical condition: In patients with progressive familial intrahepatic cholestasis (PFIC), impairment of the egress of bile acids from the liver leads to cholestasis, hepatocellular injury and damage, and progressive ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) PL (Completed) FR (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-004628-40 Sponsor Protocol Number: MRX-801 Start Date*: 2021-01-29
    Sponsor Name:Mirum Pharmaceuticals Inc
    Full Title: Open-Label, Phase 2 Study to Evaluate the Safety and Tolerability of Maralixibat in the Treatment of Infants with Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis ...
    Medical condition: Progressive Familial Intrahepatic Cholestasis and Alagille Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10076033 Progressive familial intrahepatic cholestasis PT
    20.0 10010331 - Congenital, familial and genetic disorders 10053870 Alagille syndrome PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) PL (Completed)
    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: 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: 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
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