Ursodeoxycholic acid (udca) (DrugBank: Ursodeoxycholic acid, UDCA)
13 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 6 | パーキンソン病 | 2 |
| 8 | ハンチントン病 | 0 |
| 20 | 副腎白質ジストロフィー | 0 |
| 67 | 多発性嚢胞腎 | 0 |
| 84 | サルコイドーシス | 1 |
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 35 |
| 94 | 原発性硬化性胆管炎 | 4 |
| 95 | 自己免疫性肝炎 | 0 |
| 96 | クローン病 | 0 |
| 97 | 潰瘍性大腸炎 | 0 |
| 234 | ペルオキシソーム病（副腎白質ジストロフィーを除く。） | 0 |
| 296 | 胆道閉鎖症 | 0 |
| 299 | 嚢胞性線維症 | 0 |
| 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 | NCT03840005 (ClinicalTrials.gov) | December 18, 2018 | 11/2/2019 | Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The UP Study | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial To Assess The Safety And Tolerability Of 30mg/kg Daily Ursodeoxycholic Acid (UDCA) In Patients With Parkinson's Disease (PD) | Parkinson's Disease | Drug: Ursonorm | Sheffield Teaching Hospitals NHS Foundation Trust | JP Moulton Charitable Foundation;PRO.MED.CS Praha a.s.;Clinical Trials Research Unit, University of Sheffield | Active, not recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | United Kingdom |
| 2 | EUCTR2018-001887-46-GB (EUCTR) | 08/11/2018 | 19/06/2019 | Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial to assess the safety and tolerability Of 30mg/kg daily Ursodeoxycholic Acid (UDCA) in Patients with Parkinson’s Disease (PD) - Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' | Parkinson’s disease (PD) MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Sheffield Teaching Hospitals NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | United Kingdom |
| 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 | NCT03602976 (ClinicalTrials.gov) | August 20, 2018 | 19/7/2018 | Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis | A Single-center, Open Label, Cross-over Study on the Effects of Ursodeoxycholic Acid (UDCA) in Patients With Hepatic Sarcoidosis | Hepatic Sarcoidosis, Elevated Alkaline Phosphatase | Drug: Ursodeoxycholic Acid | Ethan Weinberg | American Association for the Study of Liver Diseases;Exalenz Bioscience LTD. | Recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 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 | NCT04620733 (ClinicalTrials.gov) | January 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: 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) | Primary Biliary Cholangitis | Drug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mg | CymaBay Therapeutics, Inc. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 180 | Phase 3 | NULL |
| 2 | NCT03954327 (ClinicalTrials.gov) | September 2020 | 7/5/2019 | Combination Antiretroviral Therapy (cART) for PBC | Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: Emtricitabine (FTC)/Tenofovir Disoproxil (TDF);Drug: Raltegravir;Drug: Placebo Oral Capsule [CEBOCAP] | University of Alberta | Merck Sharp & Dohme Corp. | Not yet recruiting | 18 Years | N/A | All | 60 | Phase 2 | Canada |
| 3 | NCT03521297 (ClinicalTrials.gov) | January 20, 2020 | 28/4/2018 | Probiotics in PBC Patients of Poor Response to UDCA | Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response | Primary Biliary Cholangitis (PBC) | Drug: Probiotic;Dietary Supplement: Placebo | Sun Yat-sen University | NULL | Not yet recruiting | 18 Years | 70 Years | All | 60 | Phase 2 | China |
| 4 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | 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 | |||
| 5 | 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 | 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 | ||
| 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 |
| 6 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | 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 | |||
| 7 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | 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 | |||
| 8 | EUCTR2017-003528-62-BE (EUCTR) | 11/01/2019 | 24/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) 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: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 9 | 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 | ||
| 10 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | 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 | |||
| 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 |
| 11 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | 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 | EUCTR2017-003528-62-DE (EUCTR) | 05/12/2018 | 16/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) 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: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 13 | EUCTR2017-003528-62-NL (EUCTR) | 29/11/2018 | 09/07/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) 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: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | United States;France;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;United Kingdom | ||
| 14 | NCT03602560 (ClinicalTrials.gov) | November 26, 2018 | 18/7/2018 | ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an 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 an Intolerance to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: seladelpar 5-10 mg;Drug: seladelpar 10 mg;Drug: Placebo | CymaBay Therapeutics, Inc. | NULL | Suspended | 18 Years | 75 Years | All | 240 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;United Kingdom |
| 15 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | 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 | |||
| 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 |
| 16 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | 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 | EUCTR2017-003528-62-AT (EUCTR) | 19/10/2018 | 25/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) 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] | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Australia;Austria;Netherlands;Germany;United Kingdom | |||
| 18 | EUCTR2017-003528-62-ES (EUCTR) | 28/08/2018 | 24/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) 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: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 19 | EUCTR2017-003528-62-GB (EUCTR) | 27/07/2018 | 22/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) 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: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 20 | NCT03394924 (ClinicalTrials.gov) | December 27, 2017 | 23/12/2017 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: EDP-305 Dose 1;Drug: EDP-305 Dose 2;Drug: Placebo | Enanta Pharmaceuticals | Pharmaceutical Research Associates;Triangle Biostatistics | Completed | 18 Years | 75 Years | All | 68 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom |
| 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 |
| 21 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Canada;Germany;United Kingdom | |||
| 22 | 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] | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | United States;Canada;Germany;United Kingdom | |||
| 23 | NCT02955602 (ClinicalTrials.gov) | November 28, 2016 | 2/11/2016 | Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) | 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 Cirrhosis | Drug: MBX-8025 2 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 10 mg Capsule | CymaBay Therapeutics, Inc. | NULL | Completed | 18 Years | 75 Years | All | 119 | Phase 2 | 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 | ||
| 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 |
| 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 | NCT02026401 (ClinicalTrials.gov) | February 2014 | 30/12/2013 | Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis | A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Biological: NGM282;Biological: Placebo | NGM Biopharmaceuticals, Inc | NGM Biopharmaceuticals Australia Pty Ltd | Completed | 18 Years | 75 Years | All | 45 | Phase 2 | United States;Australia |
| 29 | NCT01904058 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis | A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis | PBC;Primary Biliary Cirrhosis | Drug: LUM001;Drug: Placebo;Drug: Ursodeoxycholic Acid | Mirum Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 66 | Phase 2 | United States;Canada;United Kingdom |
| 30 | EUCTR2013-000482-36-GB (EUCTR) | 08/07/2013 | 13/05/2013 | Phase 2 study to investigate use of LUM001 as a treatment for Primary Biliary Cirrhosis (PBC). This is a chronic and slowly progressive cholestatic liver disease of autoimmune aetiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS. - CLARITY STUDY | Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. Affected individuals are usually in their fifthto seventh decades of life at time of diagnosis, and 90% are women. MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: LUM001 INN or Proposed INN: LUM001 | Lumena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;United Kingdom | ||
| 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 |
| 31 | EUCTR2011-000554-31-SE (EUCTR) | 26/10/2011 | 16/08/2011 | A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic Acid | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI | Primary Biliary Cirrhosis MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | France;United States;Canada;Germany;Italy;United Kingdom;Sweden | ||
| 32 | EUCTR2011-000554-31-GB (EUCTR) | 21/09/2011 | 12/07/2011 | A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic Acid | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI | Primary Biliary Cirrhosis MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | France;United States;Canada;Germany;Italy;United Kingdom;Sweden | ||
| 33 | NCT01389973 (ClinicalTrials.gov) | September 2011 | 7/7/2011 | A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cirrhosis | Drug: ustekinumab 90 mg;Drug: ustekinumab 45 mg;Drug: ustekinumab 180 mg;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 99 Years | All | 20 | Phase 2 | United States;Canada |
| 34 | NCT01141296 (ClinicalTrials.gov) | April 2011 | 8/6/2010 | Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis | Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: fenofibrate;Drug: placebo | University of Miami | Mayo Clinic | Withdrawn | 21 Years | 75 Years | Both | 0 | Phase 2 | United States |
| 35 | JPRN-C000000225 | 2003/12/01 | 13/09/2008 | Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis | Primary biliary cirrhosis | Intervention:UDCA+Bezafibrate Bezafibrate: 400mg/day for 12 months Dose of pretreatment UDCA is not changed after entry. control:UDCA only Dose of pretreatment UDCA is not changed after entry. | Gunma Liver Study Group | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 20 | Not applicable | Japan |
| 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 | NCT03678480 (ClinicalTrials.gov) | March 1, 2021 | 18/9/2018 | A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC) | A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract Diseases;Digestive System Diseases;Adolescent | Drug: HTD1801;Drug: Ursodeoxycholic Acid | HighTide Biopharma Pty Ltd | NULL | Not yet recruiting | 12 Years | 17 Years | All | 104 | Phase 2 | NULL |
| 2 | EUCTR2015-003310-24-SE (EUCTR) | 09/10/2015 | 01/09/2015 | Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) | A Phase 3, Open-label, Randomized, Prospective Clinical Trial Evaluating the Efficacy of Stratified Treatment with Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) - UDCAPSCSURV | Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Ursofalk Product Name: Ursofalk | Sahlgrenska Academy | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Sweden | |||
| 3 | NCT01456468 (ClinicalTrials.gov) | October 2011 | 14/10/2011 | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis - A Human Pilot Study | Cholangitis, Sclerosing | Drug: Oral all-trans retinoic acid (ATRA) | Yale University | Mayo Clinic | Completed | 18 Years | 80 Years | Both | 19 | Phase 1 | United States |
| 4 | NCT01088607 (ClinicalTrials.gov) | October 2010 | 12/3/2010 | Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis | Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis: A Pilot Withdrawal/Reinstitution Trial | Primary Sclerosing Cholangitis | Drug: ursodeoxycholic acid (UDCA) | University of Tennessee | Icahn School of Medicine at Mount Sinai;Ann & Robert H Lurie Children's Hospital of Chicago;University of Colorado, Denver;University of California, San Francisco;University of Pittsburgh;Phoenix Children's Hospital;Children's Hospital of Philadelphia;Children's Healthcare of Atlanta;Children's Hospital Los Angeles;Texas Children's Hospital;Yale University | Completed | 5 Years | 21 Years | All | 27 | Phase 1 | United States;Canada |