93. 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］
［臨床試験数：230，薬物数：215（DrugBank：51），標的遺伝子数：34，標的パスウェイ数：107］
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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-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] | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom | |||
| 3 | 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] | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | |||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | 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] | Genkyotex SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | |||
| 7 | NCT03226067 (ClinicalTrials.gov) | June 26, 2017 | 30/6/2017 | Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid. | 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 Cirrhosis | Drug: GKT137831;Drug: Placebo oral capsule | Genkyotex SA | NULL | Completed | 18 Years | 80 Years | All | 111 | Phase 2 | United States;Belgium;Canada;Germany;Greece;Israel;Italy;Spain;United Kingdom |