94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details
臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
Showing 1 to 10 of 30 diseases
| 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-NL (EUCTR) | 22/01/2019 | 06/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive n ... | 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 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany;Sweden Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Be ... | ||
| 2 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | 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 Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive n ... | 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 Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy; ... | ||
| 3 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - NUC-5/PSC Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid Product Code: [NorUDCA] INN or Proposed INN: ACIDO DEOSSICOLICO Other descriptive name: NorUDCA (Norursodeoxycholic acid) Product Name: Norursodeoxycholic acid Product Code: [NorUDCA] INN or Proposed INN: ACIDO DEOSSICOLICO O ... | 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 Finland;Ireland;Lithuania;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Pol ... | ||
| 4 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Nor ... | 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;Netherlands;Germany;Norway;Sweden Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy; ... | ||
| 5 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Nor ... | 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;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy; ... | ||
| 6 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive n ... | 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 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Be ... | ||
| 7 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Nor ... | 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 Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy; ... | ||
| 8 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Norursodeoxycholic acid, NCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norucholic acid Other descriptive name: Nor ... | 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 Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy; ... | ||
| 9 | 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 A study to compare norursodeoxycholic acidwith placebo in the treatment of primary sclerosing cholan ... | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acidcapsu ... | 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] Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of as ... | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive n ... | 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 Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy; ... | ||
| 10 | 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 Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic AcidCapsu ... | Primary Sclerosing Cholangitis | Drug: norUrsodeoxycholic Acid | Dr. Falk Pharma GmbH | NULL | Recruiting | 16 Years | 75 Years | All | 300 | Phase 3 | Austria;Germany |