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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 |