93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
| 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 | ChiCTR2000032053 | 2020-05-01 | 2020-04-19 | Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC) | Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC) | primary biliary cholangitis | Gold Standard:Any two of the following items met: 1. increased biochemical indicators of cholestasis such as alkaline phosphatase; 2. positive serum AMA or AMA-M2; 3. hepatic histopathology.;Index test:high-frequency and low-frequency ultrasound?transient elastography (TE); | You'an Hospital, Capital Medical University | NULL | Pending | 18 | 70 | Both | Target condition:100;Difficult condition:270 | N/A | China |
| 2 | EUCTR2016-004599-23-IT (EUCTR) | 26/02/2018 | 07/01/2021 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess theEfficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase - GSN00300 | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 | GENKYOTEX SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 3 | EUCTR2016-004599-23-GR (EUCTR) | 27/10/2017 | 06/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2016-004599-23-DE (EUCTR) | 19/09/2017 | 10/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2016-004599-23-BE (EUCTR) | 10/08/2017 | 10/04/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2016-004599-23-ES (EUCTR) | 26/07/2017 | 04/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2016-004599-23-GB (EUCTR) | 30/06/2017 | 17/05/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom |