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-IT (EUCTR) | 18/01/2022 | 05/11/2021 | 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 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | NCT05014672 (ClinicalTrials.gov) | December 2021 | 10/8/2021 | A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and 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 | Primary Biliary Cholangitis;Liver Stiffness | Drug: Setanaxib;Drug: Placebo | Genkyotex Suisse SA | NULL | Recruiting | 18 Years | N/A | All | 318 | Phase 2/Phase 3 | United States |