93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
| 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 | 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). | 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 | 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand;United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary | ||
| 2 | EUCTR2020-004348-27-RO (EUCTR) | 08/07/2021 | 19/04/2022 | 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). | 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 | 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | 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;Denmark;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 3 | 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). | 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 | 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | 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 | ||
| 4 | EUCTR2020-005198-29-NL (EUCTR) | 28/06/2021 | 31/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3;Phase 4 | 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 | ||
| 5 | 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). | 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 | 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand | ||
| 6 | EUCTR2020-005198-29-DE (EUCTR) | 10/05/2021 | 05/02/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Greece;Spain;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 7 | EUCTR2020-005198-29-HU (EUCTR) | 06/05/2021 | 21/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3;Phase 4 | 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 | ||
| 8 | EUCTR2020-005198-29-PL (EUCTR) | 05/05/2021 | 17/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | 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 | ||
| 9 | EUCTR2020-004348-27-PL (EUCTR) | 16/03/2021 | 02/02/2021 | 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). | 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 | 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand | ||
| 10 | EUCTR2020-004348-27-HU (EUCTR) | 04/03/2021 | 20/01/2021 | 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). | 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 | 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | 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 | ||
| 11 | EUCTR2018-001171-20-AT (EUCTR) | 29/04/2019 | 19/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 12 | EUCTR2018-001171-20-NL (EUCTR) | 18/04/2019 | 16/11/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;United States;Greece;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 13 | EUCTR2018-001171-20-BE (EUCTR) | 06/03/2019 | 29/01/2019 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 14 | EUCTR2018-001171-20-FR (EUCTR) | 23/01/2019 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 15 | EUCTR2018-001171-20-PL (EUCTR) | 27/12/2018 | 06/11/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 16 | EUCTR2018-001171-20-ES (EUCTR) | 21/12/2018 | 18/01/2019 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 17 | EUCTR2018-001171-20-DE (EUCTR) | 20/12/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 18 | EUCTR2018-001171-20-HU (EUCTR) | 26/11/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 19 | EUCTR2018-001171-20-GR (EUCTR) | 23/11/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 20 | EUCTR2017-003910-16-GB (EUCTR) | 08/02/2018 | 15/11/2017 | A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis | An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) | Primary Biliary Cholangitis 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] | Product Name: Seladelpar Product Code: MBX-8025, DSIC INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025, DSIC INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025, Formulation 2 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025, Formulation 2 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3;Phase 4 | Argentina;Russian Federation;Romania;Hungary;United States;United Kingdom;Spain;Greece;New Zealand;Canada;Netherlands;Belgium;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Chile;France;Serbia;Germany | ||
| 21 | EUCTR2017-003910-16-DE (EUCTR) | 29/01/2018 | 04/12/2017 | A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis | An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | 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: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2;Phase 3 | United States;Canada;Germany;United Kingdom | ||
| 22 | EUCTR2016-002996-91-DE (EUCTR) | 21/02/2017 | 17/11/2016 | A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 23 | EUCTR2016-002996-91-GB (EUCTR) | 12/01/2017 | 21/11/2016 | A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 24 | EUCTR2015-002698-39-PL (EUCTR) | 03/03/2016 | 08/01/2016 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). | Primary Biliary Cirrhosis MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 25 | EUCTR2015-002698-39-DE (EUCTR) | 18/12/2015 | 30/09/2015 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). | Primary Biliary Cirrhosis MedDRA version: 19.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 INN or Proposed INN: NA Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 INN or Proposed INN: NA Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 26 | EUCTR2015-002698-39-GB (EUCTR) | 11/11/2015 | 17/09/2015 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). | Primary Biliary Cirrhosis MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 27 | NCT02609048 (ClinicalTrials.gov) | November 2015 | 13/11/2015 | Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) | A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cirrhosis (PBC) | Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mg | CymaBay Therapeutics, Inc. | NULL | Terminated | 18 Years | 75 Years | All | 41 | Phase 2 | United States;Canada;Germany;Poland;United Kingdom |
| 28 | EUCTR2020-005198-29-FR (EUCTR) | 29/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis 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] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 500 | Phase 3;Phase 4 | 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 |