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 | EUCTR2019-000204-14-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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 |