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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-002945-39-ES (EUCTR) | 20/01/2022 | 19/10/2021 | A 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 ducts | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Spain;Israel;United Kingdom | ||
| 2 | EUCTR2020-003027-41-DE (EUCTR) | 17/11/2021 | 17/06/2021 | A study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing cholangitis | A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS) - 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 2 | United States;Canada;Israel;Germany;United Kingdom | ||
| 3 | NCT05082779 (ClinicalTrials.gov) | October 26, 2021 | 25/9/2021 | Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CS0159 | A 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 Subject | Primary Sclerosing Cholangitis (PSC) | Drug: CS0159 | Cascade Pharmaceuticals, Inc | Covance | Recruiting | 18 Years | 55 Years | All | 80 | Phase 1 | United States |
| 4 | EUCTR2020-001428-33-NL (EUCTR) | 27/07/2021 | 31/08/2020 | A 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, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 2 | France;United States;Canada;Belgium;Austria;Australia;Norway;Germany;Netherlands;United Kingdom | ||
| 5 | NCT04309773 (ClinicalTrials.gov) | April 6, 2021 | 18/10/2019 | Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy | Double 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 | Primary Sclerosing Cholangitis;Cholestasis | Drug: Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy;Drug: Placebo of Bezafibrate in addition to standard UDCA therapy | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | 75 Years | All | 104 | Phase 3 | France |
| 6 | NCT03678480 (ClinicalTrials.gov) | March 1, 2021 | 18/9/2018 | A 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;Adolescent | Drug: HTD1801;Drug: Ursodeoxycholic Acid | HighTide Biopharma Pty Ltd | NULL | Withdrawn | 12 Years | 17 Years | All | 0 | Phase 2 | NULL |
| 7 | EUCTR2020-001428-33-DE (EUCTR) | 15/02/2021 | 17/07/2020 | A 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, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Phase 2 | France;United States;Canada;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 8 | NCT04663308 (ClinicalTrials.gov) | December 18, 2020 | 17/11/2020 | A 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 Cholangitis | Primary Sclerosing Cholangitis | Drug: Volixibat;Drug: Placebo | Mirum Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 200 | Phase 2 | United States |
| 9 | EUCTR2020-001428-33-GB (EUCTR) | 05/11/2020 | 22/06/2020 | A 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, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Phase 2 | United States;France;Canada;Belgium;Austria;Australia;Norway;Netherlands;Germany;United Kingdom | ||
| 10 | NCT04595825 (ClinicalTrials.gov) | October 1, 2020 | 7/10/2020 | CM-101 in PSC Patients -The SPRING Study | A 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 | Biological: CM-101;Other: Placebo | ChemomAb Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 45 | Phase 2 | Germany;Israel;United Kingdom |
| 11 | NCT04133792 (ClinicalTrials.gov) | October 1, 2020 | 17/10/2019 | Effect 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 Study | Primary Sclerosing Cholangitis | Drug: Simvastatin 40mg;Drug: Placebo oral tablet | Annika Bergquist | NULL | Recruiting | 18 Years | 75 Years | All | 700 | Phase 3 | Sweden |
| 12 | NCT04480840 (ClinicalTrials.gov) | July 27, 2020 | 13/7/2020 | Phase 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 Cholangitis | Drug: PLN-74809;Drug: Placebo | Pliant Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 84 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Germany;Netherlands;United Kingdom |
| 13 | EUCTR2019-001015-23-FR (EUCTR) | 13/05/2020 | 04/06/2020 | Study evaluating the efficacy of bezafibrate for people suffering of primary sclerosing cholangitis | Double 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) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 104 | Phase 3 | France | ||
| 14 | EUCTR2019-002945-39-GB (EUCTR) | 15/04/2020 | 14/11/2019 | A 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 ducts | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Israel;United Kingdom | ||
| 15 | NCT03710122 (ClinicalTrials.gov) | January 23, 2020 | 15/10/2018 | Vancomycin for Primary Sclerosing Cholangitis | A Prospective, Randomized, Multi-centered, Placebo-controlled Clinical Trial of Oral Vanycomycin in Adults With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Vancomycin;Other: Placebo | Elizabeth Carey | Arizona State University | Recruiting | 18 Years | 75 Years | All | 102 | Phase 2/Phase 3 | United States;Canada |
| 16 | EUCTR2019-000204-14-AT (EUCTR) | 13/12/2019 | 26/06/2019 | A 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 421 | Phase 3 | United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden | ||
| 17 | NCT04024813 (ClinicalTrials.gov) | November 12, 2019 | 20/6/2019 | A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With 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 | Drug: Seladelpar;Drug: Placebo to match Seladelpar | CymaBay Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 1 | Phase 2 | United States;Canada;Poland |
| 18 | EUCTR2019-000204-14-DK (EUCTR) | 08/11/2019 | 08/07/2019 | A 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 421 | Phase 3 | United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden | ||
| 19 | NCT04060147 (ClinicalTrials.gov) | October 17, 2019 | 15/8/2019 | Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis | A Proof-of-Concept, Open-Label Study Evaluating the Safety and Tolerability of Cilofexor in Subjects With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis | Primary Sclerosing Cholangitis;Compensated Cirrhosis | Drug: CILO | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 11 | Phase 1 | United States |
| 20 | EUCTR2019-001760-30-GB (EUCTR) | 11/10/2019 | 27/06/2019 | The 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 Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Poland;Australia;Israel;Germany;United Kingdom | ||
| 21 | EUCTR2019-000204-14-FR (EUCTR) | 26/09/2019 | 02/08/2019 | A 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. | NULL | Authorised-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): no | United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden | ||
| 22 | EUCTR2019-001760-30-PL (EUCTR) | 18/09/2019 | 18/07/2019 | The 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 Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Poland;Australia;Israel;Germany;United Kingdom | ||
| 23 | EUCTR2019-000204-14-FI (EUCTR) | 11/09/2019 | 24/06/2019 | A 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 421 | Phase 3 | United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden | ||
| 24 | EUCTR2019-000204-14-ES (EUCTR) | 29/08/2019 | 12/09/2019 | A 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden | ||
| 25 | EUCTR2019-000204-14-GB (EUCTR) | 15/07/2019 | 27/06/2019 | A 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 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Finland;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden | ||
| 26 | EUCTR2019-000204-14-IT (EUCTR) | 12/07/2019 | 29/01/2021 | A 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 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 INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden | ||
| 27 | NCT03722576 (ClinicalTrials.gov) | June 17, 2019 | 25/10/2018 | Vidofludimus Calcium for Primary Sclerosing Cholangitis | Investigation 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 Cholangitis | Drug: Vidofludimus calcium | Elizabeth Carey | Arizona State University | Completed | 18 Years | 75 Years | All | 14 | Phase 2 | United States |
| 28 | NCT03890120 (ClinicalTrials.gov) | March 27, 2019 | 25/3/2019 | Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Cilofexor;Drug: Placebo | Gilead Sciences | NULL | Active, not recruiting | 18 Years | 75 Years | All | 419 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;Finland;France;Germany;Israel;Italy;Japan;New Zealand;Spain;Switzerland;United Kingdom |
| 29 | EUCTR2018-004258-77-GB (EUCTR) | 05/02/2019 | 26/11/2018 | A 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-101 | ChemomAb Ltd. | NULL | Not 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): no | Israel;United Kingdom | ||
| 30 | EUCTR2016-003367-19-NL (EUCTR) | 22/01/2019 | 06/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-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): no | Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 31 | NCT02997878 (ClinicalTrials.gov) | December 7, 2018 | 13/12/2016 | A Single-arm,Phase IIa,Safety and Efficacy Trial of Selected MSCs in the Treatment of Patients With PSC & AiH | An 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 Hepatitis | Cholangitis, Sclerosing;Hepatitis, Autoimmune | Biological: Orbcel-C | University of Birmingham | European Union;NHS Blood and Transplant | Recruiting | 18 Years | 70 Years | All | 56 | Phase 1/Phase 2 | United Kingdom |
| 32 | EUCTR2016-003367-19-PL (EUCTR) | 20/11/2018 | 28/05/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 33 | EUCTR2016-003367-19-IT (EUCTR) | 22/10/2018 | 05/01/2021 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Finland;Ireland;Lithuania;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 34 | NCT03561584 (ClinicalTrials.gov) | July 1, 2018 | 14/5/2018 | Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis | A Randomized, Placebo-controlled Pilot Study of Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis | Drug: Sulfasalazine;Drug: Placebo | Brigham and Women's Hospital | NULL | Recruiting | 15 Years | 80 Years | All | 42 | Phase 2 | United States |
| 35 | NCT03359174 (ClinicalTrials.gov) | May 29, 2018 | 27/11/2017 | An Efficacy Trial of Low Dose All-trans Retinoic Acid in Patients With Primary Sclerosing Cholangitis | An Efficacy Trial of Low Dose All-trans Retinoic Acid (ATRA) in Patients With Primary Sclerosing Cholangitis | Cholangitis, Sclerosing | Drug: All-trans retinoic acid | Yale University | NULL | Terminated | 18 Years | 80 Years | All | 2 | Phase 2 | United States |
| 36 | EUCTR2016-003367-19-SE (EUCTR) | 25/04/2018 | 12/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 37 | EUCTR2016-003367-19-CZ (EUCTR) | 09/04/2018 | 08/01/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Poland;Denmark;Germany;Netherlands;Norway;Sweden;Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium | ||
| 38 | EUCTR2016-003367-19-FR (EUCTR) | 06/04/2018 | 08/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-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): no | Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 39 | EUCTR2016-003367-19-BE (EUCTR) | 30/03/2018 | 09/01/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 40 | EUCTR2016-003367-19-DK (EUCTR) | 20/03/2018 | 01/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 41 | EUCTR2016-003367-19-GB (EUCTR) | 12/02/2018 | 21/07/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 42 | NCT03333928 (ClinicalTrials.gov) | February 9, 2018 | 27/10/2017 | A POC and Dose-Ranging Study of HTD1801 in PSC Patients | A 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: Placebo | HighTide Biopharma Pty Ltd | NULL | Completed | 18 Years | 75 Years | All | 59 | Phase 2 | United States;Canada |
| 43 | NCT03872921 (ClinicalTrials.gov) | February 8, 2018 | 8/3/2019 | norUrsodeoxycholic Acid vs Placebo in PSC | Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: norUrsodeoxycholic Acid | Dr. Falk Pharma GmbH | NULL | Recruiting | 16 Years | 75 Years | All | 300 | Phase 3 | Austria;Germany |
| 44 | NCT03394781 (ClinicalTrials.gov) | January 22, 2018 | 3/1/2018 | A 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 Cholangitis | Drug: DUR-928 | Durect | NULL | Terminated | 18 Years | 80 Years | All | 5 | Phase 2 | United States |
| 45 | EUCTR2016-003367-19-FI (EUCTR) | 09/01/2018 | 11/12/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 46 | EUCTR2016-003367-19-LT (EUCTR) | 29/12/2017 | 04/12/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 47 | EUCTR2014-001438-27-ES (EUCTR) | 29/11/2017 | 10/10/2017 | The effect of bezafibrate on itch in a subset of liver diseases | The 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 Center | NULL | Not 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): no | Spain;Netherlands | ||
| 48 | NCT03183570 (ClinicalTrials.gov) | November 8, 2017 | 8/5/2017 | Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT | Detection of Integrin avb6 in Idiopathic Pulmonary Fibrosis, Primary Sclerosing Cholangitis, and Coronavirus Disease 2019 With [18F]FP-R01-MG-F2 With PET/CT | Idiopathic Pulmonary Fibrosis;Primary Sclerosing Cholangitis;Covid19 Pneumonia | Drug: [18F]FP-R01-MG-F2 | Stanford University | Pliant Therapeutics, Inc. | Recruiting | 18 Years | N/A | All | 30 | Early Phase 1 | United States |
| 49 | EUCTR2016-003367-19-HU (EUCTR) | 05/10/2017 | 22/08/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 50 | EUCTR2016-003367-19-DE (EUCTR) | 28/09/2017 | 19/06/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 51 | NCT03216876 (ClinicalTrials.gov) | September 2017 | 5/1/2016 | A Study Of Ursolic Acid For Primary Sclerosing Cholangitis | An Open-Label Study Of Ursolic Acid For Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Ursolic acid | University of California, Davis | NULL | Withdrawn | 18 Years | 70 Years | All | 0 | Phase 1 | United States |
| 52 | EUCTR2016-003367-19-AT (EUCTR) | 01/08/2017 | 27/06/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 53 | NCT04006886 (ClinicalTrials.gov) | July 11, 2017 | 2/7/2019 | Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) | Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC) - a Pilot-Study | Reduction of Intestinal Inflammatory Activity | Dietary Supplement: Gluten-free diet | Universitätsklinikum Hamburg-Eppendorf | Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel;Johannes Gutenberg University Mainz | Completed | 18 Years | 65 Years | All | 17 | N/A | Germany |
| 54 | NCT02978339 (ClinicalTrials.gov) | June 9, 2017 | 22/11/2016 | A 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 Cholangitis | Primary Sclerosing Cholangitis | Drug: Curcumin | John E. Eaton | EuroPharma, Inc. | Completed | 18 Years | 75 Years | All | 15 | Phase 1/Phase 2 | United States |
| 55 | NCT03099603 (ClinicalTrials.gov) | March 24, 2017 | 14/3/2017 | A Study of HTD1801 in Healthy Subjects | A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects | Primary Sclerosing Cholangitis | Drug: HTD1801 | HighTide Biopharma Pty Ltd | NULL | Completed | 18 Years | 50 Years | All | 32 | Phase 1 | Australia |
| 56 | NCT03035058 (ClinicalTrials.gov) | February 2017 | 25/1/2017 | Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease | A 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 Disease | Primary Sclerosing Cholangitis;Inflammatory Bowel Disease | Drug: Vedolizumab;Drug: Placebo | Takeda | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | NULL |
| 57 | EUCTR2016-002442-23-AT (EUCTR) | 31/01/2017 | 21/12/2016 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without Cirrhosis | A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis | 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. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom;Austria;Canada;United States | ||
| 58 | EUCTR2016-002442-23-GB (EUCTR) | 09/01/2017 | 16/11/2016 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without Cirrhosis | A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis | 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. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Canada;Austria;United Kingdom | ||
| 59 | NCT03516006 (ClinicalTrials.gov) | January 2017 | 20/9/2017 | Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: UCMSC;Drug: UDCA | Fuzhou General Hospital | NULL | Active, not recruiting | 18 Years | 65 Years | All | 20 | Phase 1/Phase 2 | NULL |
| 60 | NCT03046901 (ClinicalTrials.gov) | December 7, 2016 | 31/1/2017 | Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients | Oral Vancomycin Treatment in Recurrent Primary Sclerosing Cholangitis in Liver Transplant Recipients | Primary Sclerosing Cholangitis;Post- Orthotopic Liver Transplantation | Drug: Vancomycin | Ochsner Health System | NULL | Withdrawn | N/A | N/A | All | 0 | N/A | United States |
| 61 | NCT02943460 (ClinicalTrials.gov) | November 29, 2016 | 13/6/2016 | Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis | A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Subjects With Primary Sclerosing Cholangitis Without Cirrhosis | Primary Sclerosing Cholangitis | Drug: Cilofexor;Drug: Placebo to match Cilofexor | Gilead Sciences | NULL | Completed | 18 Years | 70 Years | All | 52 | Phase 2 | United States;Austria;Canada;United Kingdom |
| 62 | JPRN-UMIN000022897 | 2016/07/15 | 15/07/2016 | Rituximab induction for liver transplantation to prevent recurrence of primary sclerosing cholangitis | Primary sclerosing cholangitis | RItuximab induction for liver transplantation | Keio University Hospital | NULL | Recruiting | 2years-old | 65years-old | Male and Female | 10 | Not selected | Japan | |
| 63 | NCT02808312 (ClinicalTrials.gov) | July 13, 2016 | 17/6/2016 | Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function | A 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 Function | Nonalcoholic Steatohepatitis (NASH);Primary Sclerosing Cholangitis (PSC) | Drug: Cilofexor | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 57 | Phase 1 | United States;New Zealand |
| 64 | EUCTR2014-003942-28-FR (EUCTR) | 04/07/2016 | 05/07/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 65 | EUCTR2014-003942-28-IT (EUCTR) | 20/06/2016 | 19/01/2021 | Efficacy and Safety of Vedolizumab IV in the treatment of Primary Sclerosing Cholangitis in patients with Inflammatory Bowel Disease | Randomized, 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: Entyvio | TAKEDA DEVELOPMENT CENTRE EUROPE LTD | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United 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 | ||
| 66 | EUCTR2014-003942-28-PL (EUCTR) | 15/06/2016 | 31/05/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 67 | EUCTR2014-003942-28-ES (EUCTR) | 29/05/2016 | 24/02/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 68 | EUCTR2014-003942-28-GB (EUCTR) | 26/05/2016 | 18/03/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 69 | EUCTR2014-003942-28-BE (EUCTR) | 13/05/2016 | 10/03/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 70 | EUCTR2014-003942-28-HU (EUCTR) | 09/05/2016 | 21/03/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 71 | EUCTR2014-003942-28-DE (EUCTR) | 09/05/2016 | 23/03/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 72 | EUCTR2015-003392-30-NL (EUCTR) | 02/05/2016 | 17/12/2015 | The 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. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;United States;Netherlands;United Kingdom | ||
| 73 | EUCTR2015-003392-30-GB (EUCTR) | 18/04/2016 | 14/12/2015 | The 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. | NULL | Not 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): no | France;United States;Netherlands;United Kingdom | ||
| 74 | EUCTR2014-003942-28-AT (EUCTR) | 13/04/2016 | 24/03/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 75 | EUCTR2014-003942-28-CZ (EUCTR) | 12/04/2016 | 24/03/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 76 | JPRN-UMIN000021411 | 2016/04/01 | 01/04/2016 | clinical efficacy of oral administration of metronidazole in the treatment of primary sclerosing cholangitis | clinical 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 cholangitis | Patients take metronidazole 250mg orally three times day for 3 weeks. | Keio University, School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 77 | EUCTR2014-003942-28-SE (EUCTR) | 30/03/2016 | 21/03/2016 | Efficacy and Safety of Vedolizumab IV in the treatment of PrimarySclerosing Cholangitis in patients with Inflammatory Bowel Disease | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 258 | Phase 3 | United States;Finland;Spain;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany;Japan;Sweden | ||
| 78 | NCT02653625 (ClinicalTrials.gov) | March 14, 2016 | 8/1/2016 | PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis | PERSEUS: 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 Cholangitis | Drug: Cenicriviroc 150 mg | Tobira Therapeutics, Inc. | NULL | Completed | 18 Years | 75 Years | All | 24 | Phase 2 | United States;Canada |
| 79 | NCT02704364 (ClinicalTrials.gov) | March 2016 | 29/2/2016 | Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis | 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 | Primary Sclerosing Cholangitis | Biological: NGM282;Other: Placebo | NGM Biopharmaceuticals, Inc | NULL | Completed | 18 Years | 75 Years | All | 62 | Phase 2 | United States;France;Netherlands;United Kingdom |
| 80 | NCT02424175 (ClinicalTrials.gov) | February 1, 2016 | 18/4/2015 | Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis. | Fecal Microbiota Transplantation for the Treatment of Primary Sclerosing Cholangitis. | Sclerosing Cholangitis | Biological: Fecal Microbiota Transplantation | Brigham and Women's Hospital | NULL | Completed | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| 81 | NCT02701166 (ClinicalTrials.gov) | February 2016 | 2/3/2016 | The Effect of Bezafibrate on Cholestatic Itch | The Effect of Bezafibrate on Cholestatic Itch | Primary Biliary Cholangitis;Primary Sclerosing Cholangitis;Secondary Sclerosing Cholangitis | Drug: Bezafibrate;Drug: Placebo | Academisch 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 Humanitas | Recruiting | 18 Years | N/A | Both | 84 | Phase 3 | Netherlands;Spain |
| 82 | NCT03069976 (ClinicalTrials.gov) | January 2016 | 28/2/2017 | Overlap 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 Children | Primary Sclerosing Cholangitis;Autoimmune Hepatitis;Overlap Syndrome | Drug: Metronidazole | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Recruiting | 3 Years | 25 Years | All | 20 | N/A | Belgium |
| 83 | EUCTR2014-002205-38-IT (EUCTR) | 02/12/2015 | 12/02/2018 | A Study of Obeticholic Acid (OCA) in Patients with Primary Sclerosing Cholangitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis - 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Italy | ||
| 84 | EUCTR2015-003310-24-SE (EUCTR) | 09/10/2015 | 01/09/2015 | Ursodeoxycholic 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 Academy | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Sweden | ||
| 85 | NCT02239211 (ClinicalTrials.gov) | September 8, 2015 | 4/9/2014 | A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis | A 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 Cholangitis | Drug: BTT1023 | University of Birmingham | Biotie Therapies Corp.;University Hospital Birmingham;National Institute for Health Research, United Kingdom | Completed | 18 Years | 75 Years | All | 23 | Phase 2 | United Kingdom |
| 86 | NCT02605213 (ClinicalTrials.gov) | September 2015 | 31/10/2015 | Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients | Evaluation of Effectiveness and Safety of Oral Vancomycin in Treatment of Primary Sclerosing Cholangitis. | Primary Sclerosing Cholangitis | Drug: Vancomycin;Drug: Placebo | Tehran University of Medical Sciences | NULL | Recruiting | 18 Years | 60 Years | Both | 30 | Phase 4 | Iran, Islamic Republic of |
| 87 | EUCTR2014-001438-27-NL (EUCTR) | 19/08/2015 | 20/07/2015 | The effect of bezafibrate on itch in a subset of liver diseases | The 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 | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Netherlands | |||
| 88 | NCT02464020 (ClinicalTrials.gov) | July 2015 | 29/5/2015 | A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis | A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis;Inflammatory Bowel Disease | Drug: Vancomycin | University of Minnesota | NULL | Completed | 18 Years | 80 Years | All | 8 | Phase 1 | United States |
| 89 | EUCTR2014-005558-21-GB (EUCTR) | 25/03/2015 | 06/01/2015 | A 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 LLC | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;United Kingdom | ||
| 90 | NCT02177136 (ClinicalTrials.gov) | February 9, 2015 | 26/6/2014 | Obeticholic 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 Cholangitis | Primary Sclerosing Cholangitis (PSC) | Drug: OCA;Drug: Placebo | Intercept Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 77 | Phase 2 | United States;Italy;Austria;Belgium;France;Germany;Netherlands;Norway;Sweden;United Kingdom |
| 91 | EUCTR2014-002393-37-GB (EUCTR) | 06/01/2015 | 19/11/2014 | A clinical trial investigating the use of BTT1023 in patients with PSC | A single arm, two-stage, multi-centre, phase II clinical trial investigating the safety and activity of the use of BTT1023, a human monoclonal antibody targeting vascular adhesion protein (VAP-1), 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 Birmingham | NULL | Not Recruiting | Female: yes Male: yes | 59 | Phase 2 | United Kingdom | ||
| 92 | EUCTR2011-002754-31-BE (EUCTR) | 13/11/2014 | 04/07/2014 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Spain;Belgium;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 93 | NCT02061540 (ClinicalTrials.gov) | March 2014 | 11/2/2014 | Open Label Study to Evaluate Safety and Efficacy of LUM001 in Patients With Primary Sclerosing Cholangitis | 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 | Primary Sclerosing Cholangitis (PSC) | Drug: LUM001 | Mirum Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 27 | Phase 2 | United States;Canada;United Kingdom |
| 94 | JPRN-UMIN000012782 | 2014/02/01 | 01/02/2014 | Efficacy 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 University | NULL | Pending | Not applicable | Not applicable | Male and Female | 2 | Not selected | Japan | |
| 95 | EUCTR2012-002473-61-BE (EUCTR) | 16/12/2013 | 02/09/2013 | An 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 96 | EUCTR2012-002473-61-NL (EUCTR) | 12/12/2013 | 04/10/2013 | An 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 97 | EUCTR2012-002473-61-SE (EUCTR) | 26/06/2013 | 20/03/2013 | An 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden | ||
| 98 | EUCTR2012-002473-61-ES (EUCTR) | 21/06/2013 | 09/04/2013 | An 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden | ||
| 99 | EUCTR2012-002473-61-IT (EUCTR) | 18/06/2013 | 04/04/2013 | 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) | 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 100 | NCT01879735 (ClinicalTrials.gov) | June 2013 | 11/6/2013 | Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT | Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT | Cholestasis;Primary Sclerosing Cholangitis;Primary Biliary Cirrhosis | Drug: 11C-CSar;Drug: ICG | University of Aarhus | NULL | Completed | 18 Years | N/A | All | 22 | Phase 1 | Denmark |
| 101 | EUCTR2012-002473-61-GB (EUCTR) | 17/05/2013 | 13/03/2013 | An 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 Inc | NULL | Not 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): no | France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 102 | EUCTR2012-002473-61-DK (EUCTR) | 14/05/2013 | 08/04/2013 | An 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden | ||
| 103 | EUCTR2012-002473-61-DE (EUCTR) | 08/05/2013 | 08/03/2013 | An 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 2 | France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 104 | EUCTR2009-018034-11-SE (EUCTR) | 29/04/2013 | 21/06/2011 | Open 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 Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Sweden | |||
| 105 | EUCTR2011-002754-31-GB (EUCTR) | 27/03/2013 | 16/07/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 106 | NCT01672853 (ClinicalTrials.gov) | March 4, 2013 | 22/8/2012 | Simtuzumab (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: Placebo | Gilead Sciences | NULL | Completed | 18 Years | 70 Years | All | 235 | Phase 2 | United States;Belgium;Canada;Denmark;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 107 | EUCTR2012-004170-26-IT (EUCTR) | 04/12/2012 | 11/10/2012 | Randomized 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 GEMELLI | NULL | Not Recruiting | Female: yes Male: yes | 200 | Italy | |||
| 108 | NCT01755507 (ClinicalTrials.gov) | December 2012 | 19/12/2012 | Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis | 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 | Primary Sclerosing Cholangitis | Drug: norUDCA;Drug: Placebo | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 80 Years | Both | 159 | Phase 2 | Austria;Germany;Norway |
| 109 | EUCTR2011-002754-31-NO (EUCTR) | 13/11/2012 | 28/06/2012 | Double-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 GmbH | NULL | Not 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): no | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden | ||
| 110 | EUCTR2011-002754-31-ES (EUCTR) | 12/11/2012 | 19/07/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 111 | EUCTR2011-002754-31-FI (EUCTR) | 19/10/2012 | 02/08/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 112 | EUCTR2011-002754-31-NL (EUCTR) | 01/10/2012 | 13/06/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Germany;Netherlands;United Kingdom;Sweden | ||
| 113 | EUCTR2011-002754-31-DK (EUCTR) | 21/09/2012 | 17/08/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Austria;Denmark;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 114 | EUCTR2011-002754-31-LT (EUCTR) | 12/09/2012 | 21/06/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 115 | EUCTR2011-002754-31-SE (EUCTR) | 11/09/2012 | 09/07/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 116 | NCT01688024 (ClinicalTrials.gov) | September 2012 | 10/9/2012 | Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis | Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Mitomycin C;Drug: Normal saline | Li, Zhiping, M.D. | Johns Hopkins University | Recruiting | 18 Years | N/A | Both | 130 | Phase 2 | United States |
| 117 | EUCTR2011-002754-31-HU (EUCTR) | 09/08/2012 | 14/08/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 118 | EUCTR2011-002754-31-DE (EUCTR) | 02/08/2012 | 11/05/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 119 | NCT01695174 (ClinicalTrials.gov) | August 2012 | 25/9/2012 | A Pilot Study of Xifaxan to Treat Patients With PSC | A Pilot Study of Xifaxan in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis (PSC) | Drug: Xifaxan | Mayo Clinic | NULL | Completed | 18 Years | 75 Years | Both | 16 | Phase 1 | United States |
| 120 | EUCTR2011-002754-31-AT (EUCTR) | 12/07/2012 | 05/06/2012 | Double-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 GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 121 | JPRN-jRCTs051180120 | 01/04/2012 | 13/03/2019 | Examination of the mizoribine and azathioprine combination immunosuppressive therapy in primary sclerosing cholangitis | Examination 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;K830 | 1 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 Hitoshi | NULL | Complete | >= 3age old | <= 18age old | Both | 10 | Phase 2 | Japan |
| 122 | JPRN-UMIN000029482 | 2012/04/01 | 10/10/2017 | 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 - A multicenter study for combination immunosuppressive therapy with mizoribine and azathioprine - - Study of combination immunosuppressive therapy in primary sclerosing cholangitis | Primary sclerosing cholangitis | Administration of mizoribine and azathioprine | Osaka General Medical Center | NULL | Complete: follow-up continuing | Not applicable | Not applicable | Male and Female | 10 | Not selected | Japan |
| 123 | NCT01802073 (ClinicalTrials.gov) | January 2012 | 21/2/2013 | Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects | Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects | Primary Sclerosing Cholangitis | Drug: Oral Vancomycin | Stanford University | NULL | Completed | 1 Year | N/A | All | 34 | Phase 3 | United States |
| 124 | NCT01549795 (ClinicalTrials.gov) | January 2012 | 7/3/2012 | Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy | Trapianto di Fegato Per Colangiocarcinoma (CCA) Ilare in Associazione a Radio e Chemioterapia Neoadiuvante | Hilar Cholangiocarcinoma;Primary Sclerosing Cholangitis | Procedure: Liver transplantation;Radiation: 45 Gy external radiations;Radiation: Endoluminal bile duct Brachytherapy;Drug: Capecitabine;Procedure: Pre liver transplantation laparoscopic hand assisted staging | Azienda Ospedaliera di Padova | NULL | Recruiting | 18 Years | 65 Years | Both | 33 | N/A | Italy |
| 125 | NCT01456468 (ClinicalTrials.gov) | October 2011 | 14/10/2011 | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis - A Human Pilot Study | Cholangitis, Sclerosing | Drug: Oral all-trans retinoic acid (ATRA) | Yale University | Mayo Clinic | Completed | 18 Years | 80 Years | Both | 19 | Phase 1 | United States |
| 126 | NCT01088607 (ClinicalTrials.gov) | October 2010 | 12/3/2010 | Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis | Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis: A Pilot Withdrawal/Reinstitution Trial | Primary Sclerosing Cholangitis | Drug: ursodeoxycholic acid (UDCA) | University of Tennessee | Icahn 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 University | Completed | 5 Years | 21 Years | All | 27 | Phase 1 | United States;Canada |
| 127 | NCT01142323 (ClinicalTrials.gov) | October 2010 | 10/6/2010 | Pilot Study of Fenofibrate for PSC | Pilot Study of Fenofibrate in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: fenofibrate | University of Miami | University of Florida | Terminated | 18 Years | 75 Years | All | 8 | Phase 1/Phase 2 | United States |
| 128 | NCT02137668 (ClinicalTrials.gov) | July 2010 | 12/5/2014 | Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin | The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin | Primary Sclerosing Cholangitis;Biliary Atresia | Drug: Oral Vancomycin | Sacramento Pediatric Gastroenterology | NULL | Recruiting | N/A | 40 Years | Both | 200 | Phase 1 | United States |
| 129 | JPRN-UMIN000003802 | 2010/04/01 | 22/06/2010 | Efficacy 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 1-4months | Saiseikai Yokohama City Tobu Hospital | Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo (Tokyo) | Recruiting | Not applicable | Not applicable | Male and Female | 15 | Not selected | Japan | |
| 130 | NCT01085760 (ClinicalTrials.gov) | February 2010 | 10/3/2010 | A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis | A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Vancomycin;Drug: Metronidazole | Mayo Clinic | PSC Partners Seeking a Cure Foundation | Completed | 18 Years | 75 Years | All | 35 | Phase 1 | United States |
| 131 | NCT00955149 (ClinicalTrials.gov) | August 2009 | 5/8/2009 | Erlotinib for Chemoprevention in Trisomy 7 Positive Primary Sclerosing Cholangitis (PSC) | An Open Label Pilot Trial of Erlotinib (Tarceva) in Primary Sclerosing Cholangitis With Trisomy 7 | Primary Sclerosing Cholangitis;Trisomy 7;Cholangiocarcinoma;Chemoprevention | Drug: Erlotinib (Tarceva) | Mayo Clinic | Genentech, Inc. | Completed | 18 Years | N/A | Both | 6 | Phase 1 | United States |
| 132 | NCT01322386 (ClinicalTrials.gov) | May 2007 | 10/2/2011 | Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin | The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin. | Primary Sclerosing Cholangitis;Biliary Atresia | Drug: Vancomycin | Stanford University | NULL | Completed | 1 Month | 20 Years | All | 32 | Phase 1 | NULL |
| 133 | NCT00953615 (ClinicalTrials.gov) | April 2006 | 4/8/2009 | Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC) | Open Label, Phase II Investigation of Thalidomide for the Treatment of Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: Thalidomide | Mayo Clinic | Celgene Corporation | Terminated | 18 Years | 72 Years | All | 1 | Phase 2 | United States |
| 134 | NCT00325013 (ClinicalTrials.gov) | December 2005 | 10/5/2006 | Evaluation of DHA for the Treatment of PSC | Evaluation of Docosahexaenoic Acid (DHA) for the Treatment of Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis;Colitis | Drug: Docosahexaenoic Acid (DHA) | Beth Israel Deaconess Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 80 Years | Both | 10 | Phase 1 | United States |
| 135 | EUCTR2005-001454-24-LT (EUCTR) | 08/06/2005 | 04/05/2005 | An 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 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Lithuania | ||
| 136 | NCT00161148 (ClinicalTrials.gov) | January 2005 | 8/9/2005 | Probiotics in Patients With Primary Sclerosing Cholangitis | Probiotics in Patients With Primary Sclerosing Cholangitis and Inflammatory Bowel Disease- a Randomized Placebo-Controlled Cross-Over Trial | Primary Sclerosing Cholangitis | Drug: Probiotics | UMC Utrecht | NULL | Recruiting | 18 Years | N/A | Both | 12 | Phase 3 | Netherlands |
| 137 | NCT00059202 (ClinicalTrials.gov) | April 2003 | 21/4/2003 | Trial of High-dose Urso in Primary Sclerosing Cholangitis | Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis | Sclerosing Cholangitis | Drug: Ursodeoxycholic Acid | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | 75 Years | Both | 150 | Phase 2/Phase 3 | United States |
| 138 | NCT00630942 (ClinicalTrials.gov) | February 2003 | 27/2/2008 | Minocycline in Primary Sclerosing Cholangitis (PSC) | Open Label Pilot Study Evaluating Minocycline in Patients With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis | Drug: Minocycline | Mayo Clinic | NULL | Completed | 18 Years | 75 Years | Both | 16 | Phase 1 | United States |
| 139 | NCT00004842 (ClinicalTrials.gov) | May 1997 | 24/2/2000 | Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis | Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis | Cholangitis, Sclerosing;Liver Cirrhosis, Biliary | Drug: budesonide | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Mayo Clinic | Completed | 18 Years | 70 Years | All | 22 | Phase 1 | United States |
| 140 | NCT00004762 (ClinicalTrials.gov) | December 1994 | 24/2/2000 | Phase II Pilot Study of Cladribine (2-Chlorodeoxyadenosine; 2-CdA) for Early Stage Primary Sclerosing Cholangitis | Cholangitis, Sclerosing | Drug: cladribine | National Center for Research Resources (NCRR) | Scripps Clinic | Completed | 18 Years | N/A | Both | 5 | Phase 2 | NULL | |
| 141 | EUCTR2016-003367-19-NO (EUCTR) | 07/03/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | NA | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | |||
| 142 | EUCTR2016-003367-19-IE (EUCTR) | 12/11/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-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 GmbH | NULL | Not 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): no | Sweden;Netherlands;Germany;Denmark;Belgium;Poland;Czech Republic;Hungary;France;United Kingdom;Switzerland;Austria;Lithuania;Ireland;Finland |