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
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 |