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 | EUCTR2021-001810-13-DE (EUCTR) | 10/02/2022 | 07/10/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden | ||
| 2 | EUCTR2021-001810-13-ES (EUCTR) | 17/01/2022 | 19/10/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 3 | EUCTR2021-001810-13-PL (EUCTR) | 11/01/2022 | 28/10/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 4 | EUCTR2021-001810-13-HU (EUCTR) | 11/12/2021 | 30/09/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden | ||
| 5 | EUCTR2021-001810-13-GR (EUCTR) | 07/12/2021 | 12/11/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 6 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 |