93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
| 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 | EUCTR2016-002443-42-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 Biliary 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 Biliary Cholangitis Without Cirrhosis | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-9674 30 mg INN or Proposed INN: not available Product Code: GS-9674 100 mg INN or Proposed INN: not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Austria;United Kingdom | ||
| 2 | EUCTR2016-002443-42-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 Biliary 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 Biliary Cholangitis Without Cirrhosis | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-9674 INN or Proposed INN: Not available Product Code: GS-9674 INN or Proposed INN: Not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Austria;United Kingdom | ||
| 3 | NCT02943447 (ClinicalTrials.gov) | December 1, 2016 | 13/6/2016 | Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary 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 Biliary Cholangitis Without Cirrhosis | Primary Biliary Cholangitis | Drug: Cilofexor;Drug: Placebo to match cilofexor | Gilead Sciences | NULL | Terminated | 18 Years | 70 Years | All | 71 | Phase 2 | United States;Austria;Canada;United Kingdom |