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 136 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 | 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 ... | ||
| 2 | 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 poten ... | 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; ... | ||
| 3 | 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 |
| 4 | NCT04956328 (ClinicalTrials.gov) | July 22, 2021 | 1/7/2021 | Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC) Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid(UDCA) in Patients With Primay B ... | A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response to UDCA . A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of ... | Primary Biliary Cirrhosis | Drug: Obeticholic Acid Tablets;Drug: UDCA;Drug: Placebo | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 120 | Phase 3 | China |
| 5 | EUCTR2020-004348-27-DE (EUCTR) | 07/07/2021 | 07/01/2021 | 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).;Therapeutic area: Body processes [G] - Immune system processes [G12] Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and poten ... | 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;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;New Zealand United States;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Ne ... | ||
| 6 | EUCTR2020-004348-27-NL (EUCTR) | 08/06/2021 | 16/03/2021 | 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).;Therapeutic area: Body processes [G] - Immune system processes [G12] Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and poten ... | 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;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexic ... | ||
| 7 | ChiCTR2100046346 | 2021-06-01 | 2021-05-14 | A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifa ... | A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifa ... | primary biliary cholangitis | Ursodeoxycholic acid group:Ursodeoxycholic acid;Rifaximin group :UDCA and rifaximin; | Xiangya Hospital of Central South University | NULL | Recruiting | 18 | 75 | Both | Ursodeoxycholic acid group:30;Rifaximin group :30; | N/A | China |
| 8 | NCT04620733 (ClinicalTrials.gov) | April 21, 2021 | 4/11/2020 | RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequat ... | 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: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Sel ... | Primary Biliary Cholangitis | Drug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mg | CymaBay Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 180 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;United Kingdom United States;Argentina;Australia;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Ko ... |
| 9 | EUCTR2019-004941-34-IT (EUCTR) | 13/04/2021 | 04/06/2021 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate t ... | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid - NA A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate t ... | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;S ... | Product Name: Elafibranor Product Code: [GFT505] | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Bra ... | ||
| 10 | NCT04618575 (ClinicalTrials.gov) | March 17, 2021 | 31/10/2020 | Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1 Ursodeoxycholic AcidCombined With Total Glucosides of Paeony in the Treatment of PBC With AIH Featur ... | A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1 A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic AcidCombined With Total Glucosi ... | Hepatitis;Primary Biliary Cholangitis;Autoimmune | Drug: Ursodeoxycholic acid combined with total glucosides of paeony;Drug: Ursodeoxycholic acid only | West China Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 137 | Phase 4 | China |