94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details


臨床試験数 : 142 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139

  
No.TrialIDDate_
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PhaseCountries
1EUCTR2019-002945-39-ES
(EUCTR)
20/01/202219/10/2021A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ductsA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CM-101
Product Code: CM-101
INN or Proposed INN: TBC
Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2
ChemomAb LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Spain;Israel;United Kingdom
2EUCTR2020-003027-41-DE
(EUCTR)
17/11/202117/06/2021A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing cholangitisA 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) - VISTAS Pruritus associated with Primary Sclerosing Cholangitis (PSC)
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: Volixibat (formely SHP626, LUM002 or SAR548304B)
INN or Proposed INN: Volixibat potassium
Other descriptive name: VOLIXIBAT
Product Name: Volixibat (formely SHP626, LUM002 or SAR548304B)
INN or Proposed INN: Volixibat potassium
Other descriptive name: VOLIXIBAT
Mirum Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Canada;Israel;Germany;United Kingdom
3NCT05082779
(ClinicalTrials.gov)
October 26, 202125/9/2021Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159A Phase I, Randomized, Double-Blind, Placebo-Contralled, Single Asending Dose / Multiple Ascending Dose Study of CS0159 to to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics, and Effect Food in Healthy SubjectPrimary Sclerosing Cholangitis (PSC)Drug: CS0159Cascade Pharmaceuticals, IncCovanceRecruiting18 Years55 YearsAll80Phase 1United States
4EUCTR2020-001428-33-NL
(EUCTR)
27/07/202131/08/2020A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis)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 (PSC) and suspected liver fibrosis (INTEGRIS-PSC) Primary sclerosing cholangitis (PSC)
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: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not yet established
Pliant Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2France;United States;Canada;Belgium;Austria;Australia;Norway;Germany;Netherlands;United Kingdom
5NCT04309773
(ClinicalTrials.gov)
April 6, 202118/10/2019Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid TherapyDouble Blind, Multicentric, Randomized, Placebo-controlled Trial, Evaluating the Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid TherapyPrimary Sclerosing Cholangitis;CholestasisDrug: Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy;Drug: Placebo of Bezafibrate in addition to standard UDCA therapyAssistance Publique - Hôpitaux de ParisNULLRecruiting18 Years75 YearsAll104Phase 3France
6NCT03678480
(ClinicalTrials.gov)
March 1, 202118/9/2018A 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 LtdNULLWithdrawn12 Years17 YearsAll0Phase 2NULL
7EUCTR2020-001428-33-DE
(EUCTR)
15/02/202117/07/2020A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis)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 (PSC) and suspected liver fibrosis (INTEGRIS-PSC) Primary sclerosing cholangitis (PSC)
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: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not yet established
Product Name: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not yet established
Pliant Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
112Phase 2France;United States;Canada;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
8NCT04663308
(ClinicalTrials.gov)
December 18, 202017/11/2020A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)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 CholangitisPrimary Sclerosing CholangitisDrug: Volixibat;Drug: PlaceboMirum Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll200Phase 2United States
9EUCTR2020-001428-33-GB
(EUCTR)
05/11/202022/06/2020A study to assess efficacy, safety and pharmacokinetics of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis)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 (PSC) and suspected liver fibrosis (INTEGRIS-PSC) Primary sclerosing cholangitis (PSC)
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: PLN-74809
Product Code: PLN-74809
INN or Proposed INN: Not yet established
Pliant Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 2United States;France;Canada;Belgium;Austria;Australia;Norway;Netherlands;Germany;United Kingdom
10NCT04133792
(ClinicalTrials.gov)
October 1, 202017/10/2019Effect 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 BergquistNULLRecruiting18 Years75 YearsAll700Phase 3Sweden
11NCT04595825
(ClinicalTrials.gov)
October 1, 20207/10/2020CM-101 in PSC Patients -The SPRING StudyA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating The Safety And Efficacy Of CM-101 In Subjects With Primary Sclerosing Cholangitis- The SPRING StudyPrimary Sclerosing CholangitisBiological: CM-101;Other: PlaceboChemomAb Ltd.NULLRecruiting18 Years75 YearsAll45Phase 2Germany;Israel;United Kingdom
12NCT04480840
(ClinicalTrials.gov)
July 27, 202013/7/2020Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)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 (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC)Primary Sclerosing CholangitisDrug: PLN-74809;Drug: PlaceboPliant Therapeutics, Inc.NULLRecruiting18 Years75 YearsAll84Phase 2United States;Australia;Austria;Belgium;Canada;Germany;Netherlands;United Kingdom
13EUCTR2019-001015-23-FR
(EUCTR)
13/05/202004/06/2020Study evaluating the efficacy of bezafibrate for people suffering of primary sclerosing cholangitisDouble blind, multicentric, randomized, placebo-controlled trial, evaluating the efficacy of 24-month of bezafibrate in primary sclerosing cholangitis with persistent cholestasis despite ursodeoxycholic acid therapy - BEZASCLER Adult patients with primary sclerosing cholangitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée
Product Name: bezafibrate
Product Code: C10AB02
INN or Proposed INN: BEZAFIBRATE
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
104Phase 3France
14EUCTR2019-002945-39-GB
(EUCTR)
15/04/202014/11/2019A study to look at how well study drug CM-101 works in people with disease of the liver and gallbladder characterized by inflammation and scarring of the bile ductsA Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial Evaluating the Safety and Efficacy of CM-101 in Subjects with Primary Sclerosing Cholangitis - The SPRING study Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CM-101
Product Code: CM-101
INN or Proposed INN: TBC
Other descriptive name: Humanised IgG1 monoclonal antibody against human eotaxin-2
ChemomAb LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Israel;United Kingdom
15NCT03710122
(ClinicalTrials.gov)
January 23, 202015/10/2018Vancomycin 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
16EUCTR2019-000204-14-AT
(EUCTR)
13/12/201926/06/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor inNon-Cirrhotic Subjects with Primary Sclerosing Cholangitis. Primary Sclerosing Cholangitis
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: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
421Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden
17NCT04024813
(ClinicalTrials.gov)
November 12, 201920/6/2019A 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.NULLCompleted18 YearsN/AAll1Phase 2United States;Canada;Poland
18EUCTR2019-000204-14-DK
(EUCTR)
08/11/201908/07/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Primary Sclerosing Cholangitis
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: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
421Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden
19NCT04060147
(ClinicalTrials.gov)
October 17, 201915/8/2019Safety 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 SciencesNULLCompleted18 YearsN/AAll11Phase 1United States
20EUCTR2019-001760-30-GB
(EUCTR)
11/10/201927/06/2019The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)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 Primary Sclerosing Cholangitis (PSC) 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 can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma.
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: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Canada;Poland;Australia;Israel;Germany;United Kingdom
21EUCTR2019-000204-14-FR
(EUCTR)
26/09/201902/08/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without Cirrhosis A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis. Primary Sclerosing Cholangitis
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 Code: GS-9674
INN or Proposed INN: cilofexor
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden
22EUCTR2019-001760-30-PL
(EUCTR)
18/09/201918/07/2019The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)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 Primary Sclerosing Cholangitis (PSC) 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 can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma.
MedDRA version: 20.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
CymaBay TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Canada;Poland;Australia;Israel;Germany;United Kingdom
23EUCTR2019-000204-14-FI
(EUCTR)
11/09/201924/06/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Primary Sclerosing Cholangitis
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: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
421Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden
24EUCTR2019-000204-14-ES
(EUCTR)
29/08/201912/09/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 inNon-Cirrhotic Subjects with Primary Sclerosing Cholangitis. Primary Sclerosing Cholangitis
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 Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden
25EUCTR2019-000204-14-GB
(EUCTR)
15/07/201927/06/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Primary Sclerosing Cholangitis
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: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden
26EUCTR2019-000204-14-IT
(EUCTR)
12/07/201929/01/2021A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis. - Not applicable Primary Sclerosing Cholangitis
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: Cilofexor
Product Code: [GS-9674]
INN or Proposed INN: Cilofexor
Product Name: Cilofexor
Product Code: [GS-9674]
INN or Proposed INN: Cilofexor
GILEAD SCIENCES INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden
27NCT03722576
(ClinicalTrials.gov)
June 17, 201925/10/2018Vidofludimus 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 UniversityCompleted18 Years75 YearsAll14Phase 2United States
28NCT03890120
(ClinicalTrials.gov)
March 27, 201925/3/2019Safety, 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 Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Cilofexor;Drug: PlaceboGilead SciencesNULLActive, not recruiting18 Years75 YearsAll419Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;Finland;France;Germany;Israel;Italy;Japan;New Zealand;Spain;Switzerland;United Kingdom
29EUCTR2018-004258-77-GB
(EUCTR)
05/02/201926/11/2018A phase 2 study being run in multiple centres to evaluate the safety, tolerability and efficacy of a study drug (called CM-101) which will be given to patients with primary sclerosing cholangitis for 12 weeks.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. - The SPRING Study Treatment of Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CM-101ChemomAb Ltd.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noIsrael;United Kingdom
30EUCTR2016-003367-19-NL
(EUCTR)
22/01/201906/02/2018A 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 cholangitis 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 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
INN or Proposed INN: Norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFinland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
31NCT02997878
(ClinicalTrials.gov)
December 7, 201813/12/2016A 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
32EUCTR2016-003367-19-PL
(EUCTR)
20/11/201828/05/2018A 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 cholangitis - norUDCA vs. Placebo in PSC 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 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
INN or Proposed INN: Norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
33EUCTR2016-003367-19-IT
(EUCTR)
22/10/201805/01/2021A 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 cholangitis - NUC-5/PSC 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 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
Product Code: [NorUDCA]
INN or Proposed INN: ACIDO DEOSSICOLICO
Other descriptive name: NorUDCA (Norursodeoxycholic acid)
DR. FALK PHARMA GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Finland;Ireland;Lithuania;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
34NCT03561584
(ClinicalTrials.gov)
July 1, 201814/5/2018Sulfasalazine 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 HospitalNULLRecruiting15 Years80 YearsAll42Phase 2United States
35NCT03359174
(ClinicalTrials.gov)
May 29, 201827/11/2017An 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 UniversityNULLTerminated18 Years80 YearsAll2Phase 2United States
36EUCTR2016-003367-19-SE
(EUCTR)
25/04/201812/02/2018A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
37EUCTR2016-003367-19-CZ
(EUCTR)
09/04/201808/01/2018A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Poland;Denmark;Germany;Netherlands;Norway;Sweden;Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium
38EUCTR2016-003367-19-FR
(EUCTR)
06/04/201808/02/2018A 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 cholangitis 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 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
INN or Proposed INN: Norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFinland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden
39EUCTR2016-003367-19-BE
(EUCTR)
30/03/201809/01/2018A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
40EUCTR2016-003367-19-DK
(EUCTR)
20/03/201801/02/2018A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
41EUCTR2016-003367-19-GB
(EUCTR)
12/02/201821/07/2017A 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 cholangitis 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 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
INN or Proposed INN: Norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
42NCT03333928
(ClinicalTrials.gov)
February 9, 201827/10/2017A 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 LtdNULLCompleted18 Years75 YearsAll59Phase 2United States;Canada
43NCT03872921
(ClinicalTrials.gov)
February 8, 20188/3/2019norUrsodeoxycholic 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 GmbHNULLRecruiting16 Years75 YearsAll300Phase 3Austria;Germany
44NCT03394781
(ClinicalTrials.gov)
January 22, 20183/1/2018A 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-928DurectNULLTerminated18 Years80 YearsAll5Phase 2United States
45EUCTR2016-003367-19-FI
(EUCTR)
09/01/201811/12/2017A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
46EUCTR2016-003367-19-LT
(EUCTR)
29/12/201704/12/2017A 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 cholangitis 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 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
INN or Proposed INN: Norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
47EUCTR2014-001438-27-ES
(EUCTR)
29/11/201710/10/2017The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCH Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezalip
INN or Proposed INN: BEZAFIBRATE
Academic Medical CenterNULLNot Recruiting Female: yes
Male: yes
84 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Netherlands
48NCT03183570
(ClinicalTrials.gov)
November 8, 20178/5/2017Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CTDetection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CTIdiopathic Pulmonary Fibrosis;Primary Sclerosing Cholangitis;Covid19 PneumoniaDrug: [18F]FP-R01-MG-F2Stanford UniversityPliant Therapeutics, Inc.Recruiting18 YearsN/AAll30Early Phase 1United States
49EUCTR2016-003367-19-HU
(EUCTR)
05/10/201722/08/2017A 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 cholangitis 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 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
INN or Proposed INN: Norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
50EUCTR2016-003367-19-DE
(EUCTR)
28/09/201719/06/2017A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
51NCT03216876
(ClinicalTrials.gov)
September 20175/1/2016A Study Of Ursolic Acid For Primary Sclerosing CholangitisAn Open-Label Study Of Ursolic Acid For Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: Ursolic acidUniversity of California, DavisNULLWithdrawn18 Years70 YearsAll0Phase 1United States
52EUCTR2016-003367-19-AT
(EUCTR)
01/08/201727/06/2017A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
53NCT04006886
(ClinicalTrials.gov)
July 11, 20172/7/2019Gluten-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 MainzCompleted18 Years65 YearsAll17N/AGermany
54NCT02978339
(ClinicalTrials.gov)
June 9, 201722/11/2016A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)An Open-Label Pilot Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: CurcuminJohn E. EatonEuroPharma, Inc.Completed18 Years75 YearsAll15Phase 1/Phase 2United States
55NCT03099603
(ClinicalTrials.gov)
March 24, 201714/3/2017A 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 LtdNULLCompleted18 Years50 YearsAll32Phase 1Australia
56NCT03035058
(ClinicalTrials.gov)
February 201725/1/2017Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel DiseaseA 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 Inflammatory Bowel DiseasePrimary Sclerosing Cholangitis;Inflammatory Bowel DiseaseDrug: Vedolizumab;Drug: PlaceboTakedaNULLWithdrawn18 YearsN/AAll0Phase 3NULL
57EUCTR2016-002442-23-AT
(EUCTR)
31/01/201721/12/2016An investigational study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA 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 Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-9674
INN or Proposed INN: Not available
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: not available
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom;Austria;Canada;United States
58EUCTR2016-002442-23-GB
(EUCTR)
09/01/201716/11/2016An investigational study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA 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 Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-9674
INN or Proposed INN: Not available
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: Not available
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Canada;Austria;United Kingdom
59NCT03516006
(ClinicalTrials.gov)
January 201720/9/2017Umbilical 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 HospitalNULLActive, not recruiting18 Years65 YearsAll20Phase 1/Phase 2NULL
60NCT03046901
(ClinicalTrials.gov)
December 7, 201631/1/2017Vancomycin 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 SystemNULLWithdrawnN/AN/AAll0N/AUnited States
61NCT02943460
(ClinicalTrials.gov)
November 29, 201613/6/2016Safety, 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 SciencesNULLCompleted18 Years70 YearsAll52Phase 2United States;Austria;Canada;United Kingdom
62JPRN-UMIN000022897
2016/07/1515/07/2016Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis Primary sclerosing cholangitisRItuximab induction for liver transplantationKeio University HospitalNULLRecruiting2years-old65years-oldMale and Female10Not selectedJapan
63NCT02808312
(ClinicalTrials.gov)
July 13, 201617/6/2016Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic FunctionA Phase 1 Open-Label, Parallel-Group, Adaptive, Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9674 in Subjects With Normal and Impaired Hepatic FunctionNonalcoholic Steatohepatitis (NASH);Primary Sclerosing Cholangitis (PSC)Drug: CilofexorGilead SciencesNULLCompleted18 YearsN/AAll57Phase 1United States;New Zealand
64EUCTR2014-003942-28-FR
(EUCTR)
04/07/201605/07/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 19.0;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
65EUCTR2014-003942-28-IT
(EUCTR)
20/06/201619/01/2021Efficacy and Safety of Vedolizumab IV in the treatment of Primary Sclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for theTreatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease - Efficacy and Safety of Vedolizumab IV in the treatment of Primary Sclerosing Cholangitis in patients Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 20.1;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: EntyvioTAKEDA DEVELOPMENT CENTRE EUROPE LTDNULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Czechia;Finland;Spain;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
66EUCTR2014-003942-28-PL
(EUCTR)
15/06/201631/05/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease - Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 19.0;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
67EUCTR2014-003942-28-ES
(EUCTR)
29/05/201624/02/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 19.0;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
68EUCTR2014-003942-28-GB
(EUCTR)
26/05/201618/03/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 18.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
69EUCTR2014-003942-28-BE
(EUCTR)
13/05/201610/03/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 18.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
70EUCTR2014-003942-28-DE
(EUCTR)
09/05/201623/03/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 18.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
71EUCTR2014-003942-28-HU
(EUCTR)
09/05/201621/03/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 18.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
72EUCTR2015-003392-30-NL
(EUCTR)
02/05/201617/12/2015The 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;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;Level: PT;Classification code 10008609;Term: Cholangitis sclerosing;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
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
NGM Biopharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Netherlands;United Kingdom
73EUCTR2015-003392-30-GB
(EUCTR)
18/04/201614/12/2015The 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;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;Level: PT;Classification code 10008609;Term: Cholangitis sclerosing;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
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
NGM Biopharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Netherlands;United Kingdom
74EUCTR2014-003942-28-AT
(EUCTR)
13/04/201624/03/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 18.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
75EUCTR2014-003942-28-CZ
(EUCTR)
12/04/201624/03/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 19.0;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
76JPRN-UMIN000021411
2016/04/0101/04/2016clinical 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 PSC primary sclerosing cholangitisPatients take metronidazole 250mg orally three times day for 3 weeks.Keio University, School of MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female20Not applicableJapan
77EUCTR2014-003942-28-SE
(EUCTR)
30/03/201621/03/2016Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel DiseaseRandomized, 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 Inflammatory Bowel Disease Primary Sclerosing Cholangitis (PSC)Inflammatory Bowel Disease (IBD)
MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871
MedDRA version: 18.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 18.1;Classification code 10021973;Term: Inflammatory bowel disease NOS;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Takeda Development Centre Europe, Ltd.NULLNot RecruitingFemale: yes
Male: yes
258Phase 3United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden
78NCT02653625
(ClinicalTrials.gov)
March 14, 20168/1/2016PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants 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 Cholangitis (PSC)Primary Sclerosing CholangitisDrug: Cenicriviroc 150 mgTobira Therapeutics, Inc.NULLCompleted18 Years75 YearsAll24Phase 2United States;Canada
79NCT02704364
(ClinicalTrials.gov)
March 201629/2/2016Phase 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, IncNULLCompleted18 Years75 YearsAll62Phase 2United States;France;Netherlands;United Kingdom
80NCT02424175
(ClinicalTrials.gov)
February 1, 201618/4/2015Fecal 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 HospitalNULLCompleted18 YearsN/AAll10Phase 1/Phase 2United States
81NCT02701166
(ClinicalTrials.gov)
February 20162/3/2016The 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
82NCT03069976
(ClinicalTrials.gov)
January 201628/2/2017Overlap Syndrome and PSC: Evaluating Role of Gut Microflora and Its Identification With Antibiotics in Children Overlap 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 LouvainNULLRecruiting3 Years25 YearsAll20N/ABelgium
83EUCTR2014-002205-38-IT
(EUCTR)
02/12/201512/02/2018A 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
INN or Proposed INN: ACIDO OBETICOLICO
Other descriptive name: ACIDO OBETICOLICO
Product Name: OCA 5 mg
Product Code: INT-747, OCA
INN or Proposed INN: ACIDO OBETICOLICO
Other descriptive name: ACIDO OBETICOLICO
INTERCEPT PHARMACEUTICALS INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United States;Italy
84EUCTR2015-003310-24-SE
(EUCTR)
09/10/201501/09/2015Ursodeoxycholic 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) - UDCAPSCSURV Primary 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
Sahlgrenska AcademyNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Sweden
85NCT02239211
(ClinicalTrials.gov)
September 8, 20154/9/2014A 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 KingdomCompleted18 Years75 YearsAll23Phase 2United Kingdom
86NCT02605213
(ClinicalTrials.gov)
September 201531/10/2015Effect 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 SciencesNULLRecruiting18 Years60 YearsBoth30Phase 4Iran, Islamic Republic of
87EUCTR2014-001438-27-NL
(EUCTR)
19/08/201520/07/2015The effect of bezafibrate on itch in a subset of liver diseasesThe effect of bezafibrate on cholestatic itch - FITCH Primary biliary cirrhosis (PBC)Primary sclerosing cholangitis (PSC)Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: BezalipAcademic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Netherlands
88NCT02464020
(ClinicalTrials.gov)
July 201529/5/2015A 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 MinnesotaNULLCompleted18 Years80 YearsAll8Phase 1United States
89EUCTR2014-005558-21-GB
(EUCTR)
25/03/201506/01/2015A phase 2a trial to evaluate the safety and tolerability of LUM001 in subjects with Primary Sclerosing Cholangitis (PSC) during 14 weeks of treatment.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 Cholangitis (PSC) - CAMEO STUDY 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 resulting in diffuse multifocal stricture formation leading to biliary cirrhosis, portal hypertension and liver failure. PSC is a life-threatening and debilitating disease. The median survival from diagnosis in symptomatic patients with PSC has been estimated to be 12 years.
MedDRA version: 17.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: LUM001
INN or Proposed INN: LUM001
Lumena Pharmaceuticals LLCNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United States;United Kingdom
90NCT02177136
(ClinicalTrials.gov)
February 9, 201526/6/2014Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)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 CholangitisPrimary Sclerosing Cholangitis (PSC)Drug: OCA;Drug: PlaceboIntercept PharmaceuticalsNULLCompleted18 Years75 YearsAll77Phase 2United States;Italy;Austria;Belgium;France;Germany;Netherlands;Norway;Sweden;United Kingdom
91EUCTR2014-002393-37-GB
(EUCTR)
06/01/201519/11/2014A clinical trial investigating the use of BTT1023 in patients with PSCA 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), in the treatment of patients with primary sclerosing cholangitis (PSC) - BUTEO: A clinical trial of BTT1023 in patients with PSC Primary Sclerosing Cholangitis (PSC)
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTT1023 IV Infusion 20 mg/mL, 5 mL Drug Product
Product Code: BTT1023
University of BirminghamNULLNot RecruitingFemale: yes
Male: yes
59Phase 2United Kingdom
92EUCTR2011-002754-31-BE
(EUCTR)
13/11/201404/07/2014Double-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 PSC primary sclerosing cholangitis
MedDRA version: 17.0;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Spain;Belgium;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
93NCT02061540
(ClinicalTrials.gov)
March 201411/2/2014Open 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.NULLCompleted18 Years80 YearsAll27Phase 2United States;Canada;United Kingdom
94JPRN-UMIN000012782
2014/02/0101/02/2014Efficacy 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 UniversityNULLPendingNot applicableNot applicableMale and Female2Not selectedJapan
95EUCTR2012-002473-61-BE
(EUCTR)
16/12/201302/09/2013An investigational study to assess the safety and efficacy of a new investigational drug 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)
MedDRA version: 18.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2France;United States;Canada;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
96EUCTR2012-002473-61-NL
(EUCTR)
12/12/201304/10/2013An investigational study to assess the safety and efficacy of a new investigational drug 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)
MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden
97EUCTR2012-002473-61-SE
(EUCTR)
26/06/201320/03/2013An investigational study to assess the safety and efficacy of a new investigational drug 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)
MedDRA version: 18.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden
98EUCTR2012-002473-61-ES
(EUCTR)
21/06/201309/04/2013An investigational study to assess the safety and efficacy of a new investigational drug 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)
MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden
99EUCTR2012-002473-61-IT
(EUCTR)
18/06/201304/04/2013A 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) 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)
MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Simtuzumab
Product Code: GS-6624
INN or Proposed INN: Simtuzimab
Product Name: Simtuzimab
Product Code: GS-6624
INN or Proposed INN: Simtuzimab
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
100NCT01879735
(ClinicalTrials.gov)
June 201311/6/2013Biliary 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 AarhusNULLCompleted18 YearsN/AAll22Phase 1Denmark
101EUCTR2012-002473-61-GB
(EUCTR)
17/05/201313/03/2013An investigational study to assess the safety and efficacy of a new investigational drug 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)
MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot Recruiting Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
102EUCTR2012-002473-61-DK
(EUCTR)
14/05/201308/04/2013An investigational study to assess the safety and efficacy of a new investigational drug 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)
MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden
103EUCTR2012-002473-61-DE
(EUCTR)
08/05/201308/03/2013An investigational study to assess the safety and efficacy of a new investigational drug 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)
MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
104EUCTR2009-018034-11-SE
(EUCTR)
29/04/201321/06/2011Open 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-psc 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 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
Trade Name: vancomycin
Product Name: Vancomycin
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Sweden
105EUCTR2011-002754-31-GB
(EUCTR)
27/03/201316/07/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 14.1;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
106NCT01672853
(ClinicalTrials.gov)
March 4, 201322/8/2012Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults 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 SciencesNULLCompleted18 Years70 YearsAll235Phase 2United States;Belgium;Canada;Denmark;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom
107EUCTR2012-004170-26-IT
(EUCTR)
04/12/201211/10/2012Randomized 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;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
INN or Proposed INN: ACETYLCYSTEINE
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLNot RecruitingFemale: yes
Male: yes
200Italy
108NCT01755507
(ClinicalTrials.gov)
December 201219/12/2012Norursodeoxycholic 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 GmbHNULLCompleted18 Years80 YearsBoth159Phase 2Austria;Germany;Norway
109EUCTR2011-002754-31-NO
(EUCTR)
13/11/201228/06/2012Double-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 PSC primary 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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden
110EUCTR2011-002754-31-ES
(EUCTR)
12/11/201219/07/2012Double-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 PSC primary 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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
111EUCTR2011-002754-31-FI
(EUCTR)
19/10/201202/08/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 17.1;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
112EUCTR2011-002754-31-NL
(EUCTR)
01/10/201213/06/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 17.0;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Germany;Netherlands;United Kingdom;Sweden
113EUCTR2011-002754-31-DK
(EUCTR)
21/09/201217/08/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 18.0;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Austria;Denmark;Norway;Netherlands;Germany;United Kingdom;Sweden
114EUCTR2011-002754-31-LT
(EUCTR)
12/09/201221/06/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 16.1;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
115EUCTR2011-002754-31-SE
(EUCTR)
11/09/201209/07/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 18.0;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
116NCT01688024
(ClinicalTrials.gov)
September 201210/9/2012Mitomycin 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
117EUCTR2011-002754-31-HU
(EUCTR)
09/08/201214/08/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 16.0;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
118EUCTR2011-002754-31-DE
(EUCTR)
02/08/201211/05/2012Double-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 PSC primary 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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
119NCT01695174
(ClinicalTrials.gov)
August 201225/9/2012A Pilot Study of Xifaxan to Treat Patients With PSCA Pilot Study of Xifaxan in Patients With Primary Sclerosing CholangitisPrimary Sclerosing Cholangitis (PSC)Drug: XifaxanMayo ClinicNULLCompleted18 Years75 YearsBoth16Phase 1United States
120EUCTR2011-002754-31-AT
(EUCTR)
12/07/201205/06/2012Double-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 PSC primary sclerosing cholangitis
MedDRA version: 16.1;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
INN or Proposed INN: norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
121JPRN-UMIN000029482
2012/04/0110/10/2017Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine -Study of combination immunosuppressive therapy in primary sclerosing cholangitis - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine - - Study of combination immunosuppressive therapy in primary sclerosing cholangitis Primary sclerosing cholangitisAdministration of mizoribine and azathioprineOsaka General Medical CenterNULLComplete: follow-up continuingNot applicableNot applicableMale and Female10Not selectedJapan
122JPRN-jRCTs051180120
01/04/201213/03/2019Examination of the mizoribine and azathioprine combination immunosuppressive therapy in primary sclerosing cholangitisExamination of the immunosuppressive drug combination therapy in primary sclerosing cholangitisStudy of the mizoribine and azathioprine combination immunosuppressive therapy - Examination of the immunosuppressive drug combination therapy in primary sclerosing cholangitis Primary sclerosing cholangitis; PSC;K8301 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.
Tajiri HitoshiNULLComplete>= 3age old<= 18age oldBoth10Phase 2Japan
123NCT01802073
(ClinicalTrials.gov)
January 201221/2/2013Primary 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 UniversityNULLCompleted1 YearN/AAll34Phase 3United States
124NCT01549795
(ClinicalTrials.gov)
January 20127/3/2012Liver 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 PadovaNULLRecruiting18 Years65 YearsBoth33N/AItaly
125NCT01456468
(ClinicalTrials.gov)
October 201114/10/2011Combination 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 ClinicCompleted18 Years80 YearsBoth19Phase 1United States
126NCT01088607
(ClinicalTrials.gov)
October 201012/3/2010Safety 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 UniversityCompleted5 Years21 YearsAll27Phase 1United States;Canada
127NCT01142323
(ClinicalTrials.gov)
October 201010/6/2010Pilot Study of Fenofibrate for PSCPilot Study of Fenofibrate in Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: fenofibrateUniversity of MiamiUniversity of FloridaTerminated18 Years75 YearsAll8Phase 1/Phase 2United States
128NCT02137668
(ClinicalTrials.gov)
July 201012/5/2014Treating 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 GastroenterologyNULLRecruitingN/A40 YearsBoth200Phase 1United States
129JPRN-UMIN000003802
2010/04/0122/06/2010Efficacy 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
130NCT01085760
(ClinicalTrials.gov)
February 201010/3/2010A 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 FoundationCompleted18 Years75 YearsAll35Phase 1United States
131NCT00955149
(ClinicalTrials.gov)
August 20095/8/2009Erlotinib 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.Completed18 YearsN/ABoth6Phase 1United States
132NCT01322386
(ClinicalTrials.gov)
May 200710/2/2011Gastrointestinal 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 UniversityNULLCompleted1 Month20 YearsAll32Phase 1NULL
133NCT00953615
(ClinicalTrials.gov)
April 20064/8/2009Thalidomide 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 CorporationTerminated18 Years72 YearsAll1Phase 2United States
134NCT00325013
(ClinicalTrials.gov)
December 200510/5/2006Evaluation 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)Completed18 Years80 YearsBoth10Phase 1United States
135EUCTR2005-001454-24-LT
(EUCTR)
08/06/200504/05/2005An 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 disease Chronic 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
RIEMSER Arzneimittel AGNULLNot RecruitingFemale: yes
Male: yes
45Phase 2Lithuania
136NCT00161148
(ClinicalTrials.gov)
January 20058/9/2005Probiotics 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 UtrechtNULLRecruiting18 YearsN/ABoth12Phase 3Netherlands
137NCT00059202
(ClinicalTrials.gov)
April 200321/4/2003Trial 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)NULLCompleted18 Years75 YearsBoth150Phase 2/Phase 3United States
138NCT00630942
(ClinicalTrials.gov)
February 200327/2/2008Minocycline in Primary Sclerosing Cholangitis (PSC)Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing CholangitisDrug: MinocyclineMayo ClinicNULLCompleted18 Years75 YearsBoth16Phase 1United States
139NCT00004842
(ClinicalTrials.gov)
May 199724/2/2000Pilot 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 ClinicCompleted18 Years70 YearsAll22Phase 1United States
140NCT00004762
(ClinicalTrials.gov)
December 199424/2/2000Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing CholangitisCholangitis, SclerosingDrug: cladribineNational Center for Research Resources (NCRR)Scripps ClinicCompleted18 YearsN/ABoth5Phase 2NULL
141EUCTR2016-003367-19-NO
(EUCTR)
07/03/2018A 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 cholangitis 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 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
INN or Proposed INN: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLNAFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
142EUCTR2016-003367-19-IE
(EUCTR)
12/11/2018A 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 cholangitis 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 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
INN or Proposed INN: Norursodeoxycholic acid
Other descriptive name: NorUDCA
Dr. Falk Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSweden;Netherlands;Germany;Denmark;Belgium;Poland;Czech Republic;Hungary;France;United Kingdom;Switzerland;Austria;Lithuania;Ireland;Finland