93. Primary biliary cholangitis Clinical trials / Disease details
Clinical trials : 282 / Drugs : 245 - (DrugBank : 56) / Drug target genes : 35 - Drug target pathways : 113
Showing 1 to 10 of 282 diseases
| 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 | NCT05190523 (ClinicalTrials.gov) | March 15, 2022 | 13/12/2021 | Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangi ... | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety an ... | Primary Biliary Cholangitis | Drug: ASC42 5 mg;Drug: ASC42 10 mg;Drug: ASC42 15 mg;Drug: Placebo | Gannex Pharma Co., Ltd. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | NULL |
| 2 | NCT05133336 (ClinicalTrials.gov) | March 15, 2022 | 1/11/2021 | Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis | A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Effica ... | Primary Biliary Cholangitis | Drug: Saroglitazar Magnesium 1 mg;Drug: Saroglitazar Magnesium 2 mg;Drug: Placebo | Zydus Therapeutics Inc. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 192 | Phase 2/Phase 3 | NULL |
| 3 | EUCTR2021-001431-56-DE (EUCTR) | 07/03/2022 | 03/11/2021 | Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver di ... | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses ... | primary biliary cholangitis 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] primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primar ... | Product Name: Norucholic acid (NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid Other descriptive name: norucholic acid Product Name: Norucholic acid(NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid ... | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Finland;Spain;Lithuania;Austria;Switzerland;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands;Norway Finland;Spain;Lithuania;Austria;Switzerland;United Kingdom;France;Belgium;Poland;Denmark;Germany;Net ... | ||
| 4 | EUCTR2020-004348-27-DK (EUCTR) | 04/03/2022 | 22/11/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cho ... | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Sel ... | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA). MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] Primary biliary cholangitis(PBC, formerly known as primary biliarycirrhosis) is a serious and potent ... | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpa ... | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Denmark;Australia;Netherlands;Germany;New Zealand;Korea, Republic of United States;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy; ... | ||
| 5 | 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 A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBCand Elevated Live ... | 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 TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Set ... | 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] Primary Biliary Cholangitis(PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classif ... | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: ... | 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 United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Ca ... | ||
| 6 | NCT05239468 (ClinicalTrials.gov) | February 2022 | 28/1/2022 | Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Patients With PBC Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Patients With P ... | A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficac ... | Primary Biliary Cholangitis | Drug: Bezafibrate 100 MG;Drug: Bezafibrate 200 MG;Drug: Obeticholic Acid 5 MG;Drug: Obeticholic Acid placebo;Drug: Bezafibrate Placebo Drug: Bezafibrate100 MG;Drug: Bezafibrate200 MG;Drug: Obeticholic Acid5 MG;Drug: Obeticholic Acidpla ... | Intercept Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States |
| 7 | NCT05104853 (ClinicalTrials.gov) | January 26, 2022 | 22/10/2021 | Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Bi ... | A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodyna ... | Primary Biliary Cholangitis | Drug: CNP-104;Drug: Placebo | COUR Pharmaceutical Development Company, Inc. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States |
| 8 | 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 A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBCand Elevated Live ... | 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 TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Set ... | 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] Primary Biliary Cholangitis(PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classif ... | 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 United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Ca ... | ||
| 9 | 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 A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBCand Elevated Live ... | 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 TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Set ... | 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] Primary Biliary Cholangitis(PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classif ... | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: ... | 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 United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Ca ... | ||
| 10 | 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 A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBCand Elevated Live ... | 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 TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Set ... | 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] Primary Biliary Cholangitis(PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classif ... | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: ... | 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 United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Ca ... |