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 94. 原発性硬化性胆管炎 [臨床試験数:68,薬物数:72(DrugBank:31),標的遺伝子数:17,標的パスウェイ数:121] 

Searched query = "Primary sclerosing cholangitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT03678480March 1, 202111 March 2019A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract Diseases;Digestive System Diseases;AdolescentDrug: HTD1801;Drug: Ursodeoxycholic AcidHighTide Biopharma Pty LtdNot recruiting12 Years17 YearsAll104Phase 2
2NCT04133792May 15, 20204 November 2019Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)Effect of Simvastatin on the Prognosis of Primary Sclerosing Cholangitis (PSC); A Randomized, Double-blind, Placebo Controlled Multicenter StudyPrimary Sclerosing CholangitisDrug: Simvastatin 40mg;Drug: Placebo oral tabletAnnika BergquistNot recruiting18 Years75 YearsAll700Phase 3
3NCT04060147October 17, 20194 November 2019Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated CirrhosisA Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated CirrhosisPrimary Sclerosing Cholangitis;Compensated CirrhosisDrug: CILOGilead SciencesRecruiting18 Years70 YearsAll20Phase 1United States
4NCT04024813August 15, 201911 November 2019A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSCA 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 Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: Seladelpar;Drug: Placebo to match SeladelparCymaBay Therapeutics, Inc.Recruiting18 YearsN/AAll100Phase 2United States;Canada;Poland
5NCT03710122June 201911 June 2019Vancomycin for Primary Sclerosing CholangitisA Prospective, Randomized, Multi-centered, Placebo-controlled Clinical Trial of Oral Vanycomycin in Adults With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Vancomycin;Other: PlaceboElizabeth CareyArizona State UniversityRecruiting18 Years75 YearsAll102Phase 2/Phase 3United States;Canada
No.TrialIDDate_
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6NCT03722576June 201911 June 2019Vidofludimus Calcium for Primary Sclerosing CholangitisInvestigation of the Activity of Vidofludimus Calcium, a Novel, Orally Available, Small Molecule Inhibitor of Dihydroorotate Dehydrogenase, as a Treatment for Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: Vidofludimus calciumElizabeth CareyArizona State UniversityNot recruiting18 Years75 YearsAll30Phase 2United States
7NCT03890120March 27, 20194 November 2019Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing CholangitisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Cilofexor;Drug: PlaceboGilead SciencesRecruiting18 Years70 YearsAll400Phase 3United States;Australia;Canada;Israel;Japan;New Zealand;Spain;Switzerland
8NCT02997878December 7, 201825 February 2019A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & AiHAn Adaptive,Multicentre, Phase IIa, Multi-disease Trial Investigating the Safety & Activity of a Single Infusion of Selected Mesenchymal Stromal Cells in the Treatment of Patients With Primary Sclerosing Cholangitis & Autoimmune HepatitisCholangitis, Sclerosing;Hepatitis, AutoimmuneBiological: Orbcel-CUniversity of BirminghamEuropean Union;NHS Blood and TransplantRecruiting18 Years70 YearsAll56Phase 1/Phase 2United Kingdom
9NCT02780752October 201815 April 2019A Study of Oral Hymecromone to Treat Adults With Primary Sclerosing CholangitisA Pilot Study of Oral Hymecromone to Treat Adults With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: hymecromoneStanford UniversityNot recruiting18 YearsN/AAll0Phase 1/Phase 2United States
10NCT03561584July 1, 201821 January 2019Sulfasalazine for the Treatment of Primary Sclerosing CholangitisA Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: Sulfasalazine;Drug: PlaceboBrigham and Women's HospitalRecruiting15 Years80 YearsAll42Phase 2United States
No.TrialIDDate_
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11NCT03359174May 29, 201815 July 2019An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing CholangitisAn Efficacy Trial of Low Dose All-trans Retinoic Acid (ATRA) in Patients With Primary Sclerosing CholangitisCholangitis, SclerosingDrug: All-trans retinoic acidYale UniversityRecruiting18 Years80 YearsAll20Phase 2United States
12NCT03333928February 9, 201811 November 2019A POC and Dose-Ranging Study of HTD1801 in PSC PatientsA Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing Cholangitis (PSC)Drug: HTD1801;Drug: PlaceboHighTide Biopharma Pty LtdRecruiting18 Years75 YearsAll90Phase 2United States
13NCT03872921February 8, 20184 November 2019norUrsodeoxycholic Acid vs Placebo in PSCDouble-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: norUrsodeoxycholic AcidDr. Falk Pharma GmbHRecruiting16 Years75 YearsAll300Phase 3Austria;Germany
14NCT03394781January 22, 201829 July 2019A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: DUR-928DurectNot recruiting18 Years80 YearsAll5Phase 2United States
15EUCTR2014-001438-27-ES29/11/20175 June 2018The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCHPrimary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezalip
Pharmaceutical Form: Coated tablet
INN or Proposed INN: BEZAFIBRATE
CAS Number: 41859-67-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Academic Medical CenterAuthorisedFemale: yes
Male: yes
84Phase 2Spain;Netherlands
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16EUCTR2016-003367-19-DE28/09/201730 April 2019A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitisPrimary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis.
MedDRA version: 20.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Norursodeoxycholic acid
Pharmaceutical Form: Capsule
INN or Proposed INN: Norursodeoxycholic acid
CAS Number: 99697-24-2
Current Sponsor code: NorUDCA
Other descriptive name: NorUDCA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHAuthorised Female: yes
Male: yes
300Phase 3Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden
17NCT03216876September 201716 December 2017A Study Of Ursolic Acid For Primary Sclerosing CholangitisAn Open-Label Study Of Ursolic Acid For Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Ursolic acidUniversity of California, DavisNot recruiting18 Years70 YearsAll0Phase 1United States
18NCT04006886July 11, 201715 July 2019Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-StudyReduction of Intestinal Inflammatory ActivityDietary Supplement: Gluten-free dietUniversitätsklinikum Hamburg-EppendorfInstitute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel;Johannes Gutenberg University MainzNot recruiting18 Years65 YearsAll17N/AGermany
19NCT02978339June 9, 20171 April 2019A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing CholangitisAn Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: CurcuminJohn E. EatonEuroPharma, Inc.Not recruiting18 Years75 YearsAll15Phase 1/Phase 2United States
20NCT03099603March 24, 201716 December 2017A Study of HTD1801 in Healthy SubjectsA First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy SubjectsPrimary Sclerosing CholangitisDrug: HTD1801HighTide Biopharma Pty LtdNot recruiting18 Years50 YearsAll32Phase 1Australia
No.TrialIDDate_
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21NCT03516006January 201711 June 2018Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing CholangitisIntra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: UCMSC;Drug: UDCAFuzhou General HospitalNot recruiting18 Years65 YearsAll20Phase 1/Phase 2
22NCT03046901December 7, 20168 April 2019Vancomycin Treatment in Recurrent PSC in Liver Transplant PatientsOral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant RecipientsPrimary Sclerosing Cholangitis;Post- Orthotopic Liver TransplantationDrug: VancomycinOchsner Health SystemNot recruitingN/AN/AAll0N/AUnited States
23NCT02943460November 29, 201626 August 2019Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without CirrhosisA Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Subjects With Primary Sclerosing Cholangitis Without CirrhosisPrimary Sclerosing CholangitisDrug: Cilofexor;Drug: Placebo to match CilofexorGilead SciencesNot recruiting18 Years70 YearsAll52Phase 2United States;Austria;Canada;United Kingdom
24JPRN-UMIN0000228972016/07/152 April 2019Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitisPrimary sclerosing cholangitisRItuximab induction for liver transplantationKeio University HospitalRecruiting2years-old65years-oldMale and Female10Not selectedJapan
25EUCTR2015-003392-30-GB18/04/201630 April 2019The testing of NGM282 for 12 weeks in patients with Primary Sclerosing Cholangitis (PSC)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 WITH PRIMARY SCLEROSING CHOLANGITIS (PSC)PRIMARY SCLEROSING CHOLANGITIS (PSC)
MedDRA version: 19.0 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0 Level: HLT Classification code 10004607 Term: Bile duct infections and inflammations System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0 Level: PT Classification code 10008609 Term: Cholangitis sclerosing System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0 Level: HLGT Classification code 10004606 Term: Bile duct disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: NGM282
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: engineered recombinant human FGF19
CAS Number: 1616639-03-2
Current Sponsor code: NGM282
Other descriptive name: rec-h-FGF19
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
Product Name: NGM282
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: engineered recombinant human FGF19
CAS Number: 1616639-03-2
Current Sponsor code: NGM282
Other descriptive name: rec-h-FGF19
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
NGM Biopharmaceuticals, Inc.Not Recruiting Female: yes
Male: yes
60Phase 2France;United States;Netherlands;United Kingdom
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26JPRN-UMIN0000214112016/04/017 October 2019clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitisclinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis - clinical efficacy of oral administration of metronidazole in the treatment of PSCprimary sclerosing cholangitisPatients take metronidazole 250mg orally three times day for 3 weeks.Keio University, School of MedicineNot Recruiting16years-oldNot applicableMale and Female20Not applicableJapan
27NCT02653625March 14, 20168 January 2018PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects With Primary Sclerosing CholangitisPERSEUS: A Phase 2 Proof of Concept Study Investigating the Preliminary Efficacy and Safety of Cenicriviroc in Adult Subjects With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Cenicriviroc 150 mgTobira Therapeutics, Inc.Not recruiting18 Years75 YearsAll24Phase 2United States;Canada
28NCT02704364March 201620 August 2018Phase 2 Study of NGM282 in Patients With Primary Sclerosing CholangitisA 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 With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisBiological: NGM282;Other: PlaceboNGM Biopharmaceuticals, IncNot recruiting18 Years75 YearsAll62Phase 2United States;France;Netherlands;United Kingdom
29NCT02424175February 1, 20169 September 2019Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis.Sclerosing CholangitisBiological: Fecal Microbiota TransplantationBrigham and Women's HospitalNot recruiting18 YearsN/AAll10Phase 1/Phase 2United States
30NCT02701166February 201611 April 2016The Effect of Bezafibrate on Cholestatic ItchThe Effect of Bezafibrate on Cholestatic ItchPrimary Biliary Cholangitis;Primary Sclerosing Cholangitis;Secondary Sclerosing CholangitisDrug: Bezafibrate;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Erasmus Medical Center;University Medical Center Groningen;Leiden University Medical Center;UMC Utrecht;Radboud University;Maastricht University Medical Center;Free University Medical Center;University of Barcelona;Ludwig-Maximilians - University of Munich;Friedrich-Alexander-Universität Erlange-Nürnberg;Istituto Clinico HumanitasRecruiting18 YearsN/ABoth84Phase 3Netherlands;Spain
No.TrialIDDate_
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31NCT03069976January 201623 April 2019Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in ChildrenOverlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Modification With Antibiotics in ChildrenPrimary Sclerosing Cholangitis;Autoimmune Hepatitis;Overlap SyndromeDrug: MetronidazoleCliniques universitaires Saint-Luc- Université Catholique de LouvainRecruiting3 Years25 YearsAll20N/ABelgium
32EUCTR2014-002205-38-IT02/12/201526 February 2018A Study of Obeticholic Acid (OCA) in Patients with Primary Sclerosing CholangitisA 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 - AESOP (Assessment of Efficacy and Safety of OCA in PSC)Primary Sclerosing Cholangitis
MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA 1,5 mg
Product Code: INT-747, OCA
Pharmaceutical Form: Tablet
INN or Proposed INN: ACIDO OBETICOLICO
CAS Number: 459789-99-2
Current Sponsor code: OCA
Other descriptive name: ACIDO OBETICOLICO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: OCA 5 mg
Product Code: INT-747, OCA
Pharmaceutical Form: Tablet
INN or Proposed INN: ACIDO OBETICOLICO
CAS Number: 459789-99-2
Current Sponsor code: OCA
Other descriptive name: ACIDO OBETICOLICO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
INTERCEPT PHARMACEUTICALS INC.AuthorisedFemale: yes
Male: yes
75Phase 2United States;Italy
33EUCTR2015-003310-24-SE09/10/201519 October 2015Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC)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 in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) - UDCAPSCSURVPrimary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy;Therapeutic area: Diseases [C] - Cancer [C04]Trade Name: Ursofalk
Product Name: Ursofalk
Pharmaceutical Form: Capsule, hard
Sahlgrenska AcademyAuthorisedFemale: yes
Male: yes
Phase 3Sweden
34NCT02239211September 8, 201513 May 2019A Trial of BTT1023 in Patients With Primary Sclerosing CholangitisA Single Arm, Two-stage, Multi-centre, Phase II Clinical Trial Investigating the Safety and Activity of the Use of BTT1023 Targeting Vascular Adhesion Protein (VAP-1), in the Treatment of Patients With Primary Sclerosing Cholangitis (PSC).Primary Sclerosing CholangitisDrug: BTT1023University of BirminghamBiotie Therapies Corp.;University Hospital Birmingham;National Institute for Health Research, United KingdomNot recruiting18 Years75 YearsAll23Phase 2United Kingdom
35NCT02605213September 201523 November 2015Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis PatientsEvaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis.Primary Sclerosing CholangitisDrug: Vancomycin;Drug: PlaceboTehran University of Medical SciencesRecruiting18 Years60 YearsBoth30Phase 4Iran, Islamic Republic of
No.TrialIDDate_
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36EUCTR2014-001438-27-NL19/08/201514 September 2015The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCHPrimary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezalip
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Academic Medical CenterAuthorisedFemale: yes
Male: yes
84Netherlands
37NCT02464020July 201523 April 2019A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing CholangitisA Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing CholangitisPrimary Sclerosing Cholangitis;Inflammatory Bowel DiseaseDrug: VancomycinUniversity of Minnesota - Clinical and Translational Science InstituteNot recruiting18 Years80 YearsAll8Phase 1United States
38NCT02061540March 20141 April 2019Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing CholangitisA 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 CholangitisPrimary Sclerosing Cholangitis (PSC)Drug: LUM001Mirum Pharmaceuticals, Inc.Not recruiting18 Years80 YearsAll27Phase 2United States;Canada;United Kingdom
39JPRN-UMIN0000127822014/02/012 April 2019Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.Group A; phenylbutyrate 6g (Child 100mg/kg)/day *7days
Group B; phenylbutyrate 6g (Child 100mg/kg)/day *3days and 12g (Child 200mg/kg)/day *4days
Group C; phenylbutyrate 6g (Child 100mg/kg)/day *1day, phenylbutyrate 12g (Child 200mg/kg)/day *2days and phenylbutyrate 21g (Child 300mg/kg)/day *4days
Juntendo UniversityNot RecruitingNot applicableNot applicableMale and Female2Not selectedJapan
40NCT01879735June 201319 October 2017Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CTHepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CTCholestasis;Primary Sclerosing Cholangitis;Primary Biliary CirrhosisDrug: 11C-CSar;Drug: ICGUniversity of AarhusNot recruiting18 YearsN/AAll22Phase 1Denmark
No.TrialIDDate_
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41EUCTR2009-018034-11-SE29/04/20133 June 2013Open pilot study of treatment with an antibiotic called vancomycin to children and adolescents with chronic inflammation of the bile ducts, called primary sclerosing cholangitis (PSC)Open pilot study of treatment with vancomycin to children and adolescents with primary sclerosing cholangitis - vanco-pscPrimary 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 transplantation (ltx). In 80% of cases PSC is associated with inflammatory bowel disease (IBD), while 3-5 % of patients with colonic IBD, suffer from the disease. The conservative treatment options are few. There is a relatively high risk of recurrency after ltx.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Vancomycin
Product Name: vancomycin
Pharmaceutical Form: Capsule
Trade Name: vancomycin
Product Name: Vancomycin
Pharmaceutical Form: Oral solution
Karolinska InstitutetAuthorisedFemale: yes
Male: yes
20Sweden
42NCT01672853February 201316 December 2017Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Subjects With Primary Sclerosing Cholangitis (PSC)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 With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing Cholangitis (PSC)Biological: Simtuzumab;Biological: PlaceboGilead SciencesNot recruiting18 Years70 YearsAll235Phase 2United States;Belgium;Canada;Denmark;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom
43EUCTR2012-004170-26-IT04/12/20122 June 2014Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.Chronic pancreatitis and primary sclerosing cholangitis
MedDRA version: 15.0 Level: PT Classification code 10033649 Term: Pancreatitis chronic System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 15.0 Level: PT Classification code 10008609 Term: Cholangitis sclerosing System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: FLUIMUCIL*20CPR EFF 600MG
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: ACETYLCYSTEINE
CAS Number: 616-91-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Pharmaceutical form of the placebo: Effervescent tablet
Route of administration of the placebo: Oral use
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINot RecruitingFemale: yes
Male: yes
200Italy
44NCT01755507December 201215 August 2016Norursodeoxycholic Acid in the Treatment of Primary Sclerosing CholangitisDouble-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: norUDCA;Drug: PlaceboDr. Falk Pharma GmbHNot recruiting18 Years80 YearsBoth159Phase 2Austria;Germany;Norway
45EUCTR2011-002754-31-NO13/11/201228 February 2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation)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 - Norursodeoxycholic acid vs. Placebo in PSCprimary sclerosing cholangitis
MedDRA version: 14.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: norursodeoxycholic acid
Pharmaceutical Form: Capsule
INN or Proposed INN: norursodeoxycholic acid
CAS Number: 99697-24-2
Other descriptive name: NorUDCA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot Recruiting Female: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden
No.TrialIDDate_
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46NCT01688024September 201219 September 2016Mitomycin C Therapy for Patients With Primary Sclerosing CholangitisPhase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Mitomycin C;Drug: Normal salineLi, Zhiping, M.D.Johns Hopkins UniversityRecruiting18 YearsN/ABoth130Phase 2United States
47EUCTR2011-002754-31-DE02/08/201225 January 2016Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation)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 - Norursodeoxycholic acid vs. Placebo in PSCprimary sclerosing cholangitis
MedDRA version: 18.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: norursodeoxycholic acid
Pharmaceutical Form: Capsule
INN or Proposed INN: norursodeoxycholic acid
CAS Number: 99697-24-2
Other descriptive name: NorUDCA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Dr. Falk Pharma GmbHNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
48NCT01695174August 201219 February 2015A Pilot Study of Xifaxan to Treat Patients With PSCA Pilot Study of Xifaxan in Patients With Primary Sclerosing CholangitisPrimary Sclerosing Cholangitis (PSC)Drug: XifaxanMayo ClinicNot recruiting18 Years75 YearsBoth16Phase 1United States
49JPRN-UMIN0000294822012/04/012 April 2019Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine -Primary sclerosing cholangitisAdministration of mizoribine and azathioprineOsaka General Medical CenterNot RecruitingNot applicableNot applicableMale and Female10Not selectedJapan
50JPRN-jRCTs05118012001/04/20122 April 2019Examination of the mizoribine and azathioprine combination immunosuppressive therapy in primary sclerosing cholangitisExamination of the immunosuppressive drug combination therapy in primary sclerosing cholangitis Study of the mizoribine and azathioprine combination immunosuppressive therapy - Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitisPrimary sclerosing cholangitis; PSC1 MZR
Daily intake of mizoribine once before breakfast. Dose adjustment is done to achieve a blood concentration level over 3.0 microg/ml at 3 hour after meal.
2)AZT
Daily intake of azathioprine once after breakfast and once after dinner.
Starting dose is 0.5-1.0mg/kg daily (max 2.0mg) , is increased according to the condition of patients. Dose is adjusted to achieve WBC 3000-5000/m3, neutrophils 2000-3500/m3(the dose of 6MP is appotoimatery half of azathioprine). Continue the dosage during a study period.
Hitoshi TajiriRecruiting318Both10Phase 2none
No.TrialIDDate_
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51NCT01549795January 201219 February 2015Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapyTrapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia NeoadiuvanteHilar Cholangiocarcinoma;Primary Sclerosing CholangitisProcedure: Liver transplantation;Radiation: 45 Gy external radiations;Radiation: Endoluminal bile duct Brachytherapy;Drug: Capecitabine;Procedure: Pre liver transplantation laparoscopic hand assisted stagingAzienda Ospedaliera di PadovaRecruiting18 Years65 YearsBoth33N/AItaly
52NCT01802073January 201216 December 2017Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating EffectsTreatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating EffectsPrimary Sclerosing CholangitisDrug: Oral VancomycinStanford UniversityNot recruiting1 YearN/AAll40Phase 3United States
53NCT01456468October 20118 August 2016Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing CholangitisCombination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis - A Human Pilot StudyCholangitis, SclerosingDrug: Oral all-trans retinoic acid (ATRA)Yale UniversityMayo ClinicNot recruiting18 Years80 YearsBoth19Phase 1United States
54NCT01088607October 201016 December 2017Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing CholangitisUrsodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis: A Pilot Withdrawal/Reinstitution TrialPrimary Sclerosing CholangitisDrug: ursodeoxycholic acid (UDCA)University of TennesseeIcahn School of Medicine at Mount Sinai;Ann & Robert H Lurie Children's Hospital of Chicago;University of Colorado, Denver;University of California, San Francisco;University of Pittsburgh;Phoenix Children's Hospital;Children's Hospital of Philadelphia;Children's Healthcare of Atlanta;Children's Hospital Los Angeles;Texas Children's Hospital;Yale UniversityNot recruiting5 Years21 YearsAll27Phase 1United States;Canada
55NCT01142323October 201012 February 2018Pilot Study of Fenofibrate for PSCPilot Study of Fenofibrate in Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: fenofibrateUniversity of MiamiUniversity of FloridaNot recruiting18 Years75 YearsAll8Phase 1/Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
56NCT02137668July 201021 November 2016Treating Primary Sclerosing Cholangitis and Biliary Atresia With VancomycinThe Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With VancomycinPrimary Sclerosing Cholangitis;Biliary AtresiaDrug: Oral VancomycinSacramento Pediatric GastroenterologyRecruitingN/A40 YearsBoth200Phase 1United States
57JPRN-UMIN0000038022010/04/012 April 2019Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome.phenylbutyrate(Child 250mg/kg/day)for 1-4months : phenylbutyrate(Child 350mg/kg/day)for 1-4months : phenylbutyrate(Child 500mg/kg/day)for 1-4monthsSaiseikai Yokohama City Tobu HospitalLaboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo (Tokyo)RecruitingNot applicableNot applicableMale and Female15Not selectedJapan
58NCT01085760February 201019 October 2017A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing CholangitisA Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Vancomycin;Drug: MetronidazoleMayo ClinicPSC Partners Seeking a Cure FoundationNot recruiting18 Years75 YearsAll35Phase 1United States
59NCT00955149August 200919 February 2015Erlotinib for Chemoprevention in Trisomy 7 Positive Primary Sclerosing Cholangitis (PSC)An Open Label Pilot Trial of Erlotinib (Tarceva) in Primary Sclerosing Cholangitis With Trisomy 7Primary Sclerosing Cholangitis;Trisomy 7;Cholangiocarcinoma;ChemopreventionDrug: Erlotinib (Tarceva)Mayo ClinicGenentech, Inc.Not recruiting18 YearsN/ABoth6Phase 1United States
60NCT01322386May 200719 October 2017Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With VancomycinThe Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin.Primary Sclerosing Cholangitis;Biliary AtresiaDrug: VancomycinStanford UniversityNot recruiting1 Month20 YearsAll32Phase 1
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
61NCT00953615April 200619 October 2017Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)Open Label, Phase II Investigation of Thalidomide for the Treatment of Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: ThalidomideMayo ClinicCelgene CorporationNot recruiting18 Years72 YearsAll1Phase 2United States
62NCT00325013December 200523 March 2015Evaluation of DHA for the Treatment of PSCEvaluation of Docosahexaenoic Acid (DHA) for the Treatment of Primary Sclerosing Cholangitis (PSC)Primary Sclerosing Cholangitis;ColitisDrug: Docosahexaenoic Acid (DHA)Beth Israel Deaconess Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting18 Years80 YearsBoth10Phase 1United States
63EUCTR2005-001454-24-LT08/06/200519 March 2012An Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With: - Chronic viral hepatitis - Chronic alcoholic liver diseases without cirrhosis - Compensated alcoholic liver cirrhosis - Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis - B025-L CHP Chronic liver diseaseAn Open Labelled, Clinical Phase II Study With Oral Cis-U-Hydroxy-L-Proline (CHP) in 45 Patients With: - Chronic viral hepatitis - Chronic alcoholic liver diseases without cirrhosis - Compensated alcoholic liver cirrhosis - Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis - B025-L CHP Chronic liver diseaseChronic viral hepatitis, Chronic alcoholic liver diseases without cirrhosis, Compensated alcoholic liver cirrhosis, Primary Billiary Cirrhosis or Primary Sclerosing Cholangitis
MedDRA version: 1.1 Level: SOC Classification code 10019805
Product Name: Cis-4-Hydroxy-L-Proline
Product Code: 3108006977
Pharmaceutical Form: Oral powder
RIEMSER Arzneimittel AGNot RecruitingFemale: yes
Male: yes
45Phase 2Lithuania
64NCT00161148January 200519 February 2015Probiotics in Patients With Primary Sclerosing CholangitisProbiotics in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Disease- a Randomized Placebo-Controlled Cross-Over TrialPrimary Sclerosing CholangitisDrug: ProbioticsUMC UtrechtRecruiting18 YearsN/ABoth12Phase 3Netherlands
65NCT00059202April 200319 February 2015Trial of High-dose Urso in Primary Sclerosing CholangitisMulticentered Randomized Trial of High-dose Urso in Primary Sclerosing CholangitisSclerosing CholangitisDrug: Ursodeoxycholic AcidNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Not recruiting18 Years75 YearsBoth150Phase 2/Phase 3United States
No.TrialIDDate_
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agemin
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agemax
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size
PhaseCountries
66NCT00630942February 200319 February 2015Minocycline in Primary Sclerosing Cholangitis (PSC)Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: MinocyclineMayo ClinicNot recruiting18 Years75 YearsBoth16Phase 1United States
67NCT00004842May 199716 December 2017Pilot Study of Budesonide for Patients With Primary Sclerosing CholangitisPilot Study of Budesonide for Patients With Primary Sclerosing CholangitisCholangitis, Sclerosing;Liver Cirrhosis, BiliaryDrug: budesonideNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Mayo ClinicNot recruiting18 Years70 YearsAll22Phase 1United States
68NCT00004762December 199419 February 2015Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing CholangitisCholangitis, SclerosingDrug: cladribineNational Center for Research Resources (NCRR)Scripps ClinicNot recruiting18 YearsN/ABoth5Phase 2

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