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 | 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Disease | Primary Sclerosing Cholangitis;Inflammatory Bowel Disease | Drug: Vedolizumab;Drug: Placebo | Takeda | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | NULL |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 |