Udca (DrugBank: UDCA)
5 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 67 | 多発性嚢胞腎 | 1 |
| 93 | 原発性胆汁性胆管炎［原発性胆汁性肝硬変 (~2017.3)］ | 68 |
| 94 | 原発性硬化性胆管炎 | 6 |
| 97 | 潰瘍性大腸炎 | 2 |
| 296 | 胆道閉鎖症 | 1 |
| 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 | JPRN-UMIN000012865 | 2014/06/30 | 01/03/2014 | Ursodeoxycholic acid for polycystic liver disease | Ursodeoxycholic acid for polycystic liver disease - UDCA for PLD | polycystic liver disease, polycystic kidney disease | UDCA 600mg/day standard treatment | Nephrology Center, Toranomon Hospital | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not selected | 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 | 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 | ChiCTR2000037244 | 2020-10-01 | 2020-08-27 | A multicenter, randomized, double-blind, Tiaomian I study of PBC | A multicenter, randomized, double-blind, Tiaomian I study of PBC | Primary biliary cholangitis | control group:UDCA+Tiaomian I placebo;experimental group:UDCA+Tiaomian I; | Longhua Hospital ShangHai University of Traditional Chinese Medicine | NULL | Recruiting | Both | control group:45;experimental group:45; | China | |||
| 3 | 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 |
| 4 | 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 |
| 5 | ChiCTR1900027043 | 2019-11-30 | 2019-10-29 | A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis | A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis | primary biliary cirrhosis | Experimental group:Sanxiao Powder and Erzhi Pill and UDCA;Control group:stimulant of Sanxiao Powder and Erzhi Pill and UDCA; | Longhua Hospital, Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Experimental group:136;Control group:136; | China | |
| 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 | ChiCTR1900026813 | 2019-11-30 | 2019-10-23 | Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine | Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine | primary biliary cholangitis | Treatment group :nourishing kidney and activating blood granule and UDCA;Control group:Simulant nourishing kidney and activating blood granule and UDCA; | Longhua Hospital, Shanghai University of traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Treatment group :120;Control group:120; | China | |
| 7 | NCT04076527 (ClinicalTrials.gov) | September 2019 | 29/8/2019 | Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis | Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis | PBC;Primary Biliary Cholangitis | Drug: UDCA;Drug: Ocaliva | University of Leipzig | RWTH Aachen University;Zentrum für Klinische Studien Leipzig;Intercept Pharma Europe Limited (IPEL);Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);University Hospital Erlangen;Medical care center for Gastroenterology, Berlin;Institute for Interdisciplinary Medicine, Hamburg;Leberhilfe Projekt gUG, Cologne;Hannover Medical School | Not yet recruiting | 18 Years | N/A | All | 1200 | Germany | |
| 8 | EUCTR2018-003365-34-GB (EUCTR) | 02/05/2019 | 11/02/2019 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA | Primary Biliary Cholangitis MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | United States;Italy;United Kingdom | |||
| 9 | 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 | |||
| 10 | 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 |
| 11 | NCT03742973 (ClinicalTrials.gov) | March 28, 2019 | 14/11/2018 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Primary Biliary Cholangitis Who Have an Inadequate Response or Are Intolerant to UDCA | Primary Biliary Cholangitis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 2 | United States;Puerto Rico;Italy;United Kingdom |
| 12 | 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 | |||
| 13 | 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 | |||
| 14 | 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 | ||
| 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 | ||
| 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-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 | |||
| 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] | 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 | |||
| 18 | ChiCTR1800020160 | 2018-12-20 | 2018-12-18 | Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis | Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis | Primary Biliary Cirrhosis | 1:Fenofibrate+UDCA;2:UDCA; | Peking Union Medical College Hosipital | NULL | Recruiting | 18 | 65 | Both | 1:20;2:20; | China | |
| 19 | 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 | ||
| 20 | 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 | ||
| 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 | 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 |
| 22 | 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 | |||
| 23 | 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 | |||
| 24 | 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 | |||
| 25 | 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 | ||
| 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 | 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 | ||
| 27 | NCT03476993 (ClinicalTrials.gov) | April 27, 2018 | 20/3/2018 | Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis | Open-label Non-comparative Study to Evaluate the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis | Liver Cirrhosis, Biliary | Biological: BCD-085 | Biocad | NULL | Terminated | 18 Years | 60 Years | All | 9 | Phase 2 | Russian Federation |
| 28 | 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 |
| 29 | 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 | |||
| 30 | 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 | |||
| 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 | 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 |
| 32 | NCT02931513 (ClinicalTrials.gov) | September 2016 | 11/10/2016 | sCD163 in PBC Patients - Assessment of Treatment Response | Macrophage Activation Marker sCD163 in PBC Patients - Assessment of Treatment Response to UDCA | Primary Biliary Cirrhosis;Liver Inflammation;Ursodeoxycholic Acid | Other: Blood samples;Device: Fibroscan;Other: Questionnaires;Biological: Liver biopsy | University of Aarhus | NULL | Recruiting | 18 Years | N/A | All | 40 | Denmark | |
| 33 | 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 | ||
| 34 | NCT02823353 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study | Primary Biliary Cirrhosis | Drug: Fenofibrate;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China |
| 35 | NCT02823366 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: Fenofibrate;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | |
| 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 |
| 36 | NCT02916290 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Fuzhenghuayu;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | |
| 37 | NCT02965911 (ClinicalTrials.gov) | January 2016 | 15/11/2016 | Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA | A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA | Primary Biliary Cirrhosis | Drug: Fenofibrate;Drug: UDCA | Beijing 302 Hospital | NULL | Recruiting | 18 Years | 65 Years | Both | 72 | Phase 1;Phase 2 | China |
| 38 | NCT02916641 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: Fuzhenghuayu;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | |
| 39 | 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 | ||
| 40 | 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 | ||
| 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 |
| 41 | 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 |
| 42 | 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 |
| 43 | 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 |
| 44 | 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 | ||
| 45 | EUCTR2007-004040-70-PL (EUCTR) | 30/04/2013 | 20/03/2013 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden | ||
| 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 |
| 46 | EUCTR2011-004681-15-AT (EUCTR) | 09/11/2011 | 19/10/2011 | Effects of the activation of PPARs in the orphan hepatic disease primary biliary cirrhosis | Effects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis - Effects of the activation of PPARs in patients with PBC | Up to 67% of PBC patients have an incomplete biochemical response to UDCA and remain at increased risk for progression to cirrhosis and liver-related death. In this study we will prospectively examine the therapeutic effects of bezafibrate (a pan-agonist activating PPARalpha/delta/gamma) in patients with early-stage PBC with a specific focus on improvement of liver functions, inflammation, lipid profile, oxidative status and endothelial function.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezafibrat Genericon retard 400 mg Product Name: Bezafibrat Product Code: 1-20190 INN or Proposed INN: BEZAFIBRATE Product Name: Ursodeoxycholsäure Other descriptive name: URSODEOXYCHOLIC ACID | Medizinische Universität Graz | NULL | Not Recruiting | Female: yes Male: yes | Austria | ||||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 |
| 50 | EUCTR2011-001326-26-IT (EUCTR) | 21/06/2011 | 19/01/2012 | Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. | Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO | Proven PBC, as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: - History of increased ALP levels for at least 6 months - Positive serum AMA titer (>1:40) - Liver biopsy consistent with PBC Patient should be on incomplete response to UDCA MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0801 Product Code: NI-0801 | NOVIMMUNE BV | NULL | Not Recruiting | Female: yes Male: yes | 40 | Italy | |||
| 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 |
| 51 | 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 |
| 52 | EUCTR2007-001425-10-AT (EUCTR) | 13/03/2009 | 27/08/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 53 | EUCTR2007-001425-10-NL (EUCTR) | 11/02/2009 | 03/09/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 54 | EUCTR2007-004040-70-DK (EUCTR) | 29/01/2009 | 19/11/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 55 | EUCTR2007-001425-10-DE (EUCTR) | 27/01/2009 | 24/10/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | United Kingdom;Germany;Netherlands;France;Spain;Austria | |||
| 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 |
| 56 | EUCTR2007-004040-70-LT (EUCTR) | 22/12/2008 | 16/09/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 57 | EUCTR2007-004040-70-FI (EUCTR) | 10/11/2008 | 25/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 58 | NCT01510860 (ClinicalTrials.gov) | November 2008 | 12/1/2012 | Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis | Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: UDCA (Ursodeoxycholic acid) | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | N/A | All | 65 | Phase 4 | Germany |
| 59 | EUCTR2007-004040-70-HU (EUCTR) | 18/10/2008 | 04/08/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 14.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 60 | EUCTR2007-001425-10-GB (EUCTR) | 13/10/2008 | 27/06/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 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 |
| 61 | EUCTR2007-001425-10-FR (EUCTR) | 26/09/2008 | 06/08/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 62 | EUCTR2007-001425-10-ES (EUCTR) | 24/09/2008 | 23/07/2008 | Estudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Estudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | cirrosis biliar primaria MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 63 | EUCTR2007-004040-70-SE (EUCTR) | 22/09/2008 | 02/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 64 | EUCTR2007-004040-70-NL (EUCTR) | 11/08/2008 | 23/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden | ||
| 65 | EUCTR2007-004040-70-DE (EUCTR) | 15/05/2008 | 14/03/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 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 |
| 66 | NCT00550862 (ClinicalTrials.gov) | October 2007 | 27/10/2007 | Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC) | A Study of INT 747 (6a-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: INT-747;Drug: Ursodeoxycholic Acid (URSO);Drug: Placebo | Intercept Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 165 | Phase 2 | United States;Austria;Canada;France;Germany;Netherlands;Spain;United Kingdom |
| 67 | EUCTR2006-003712-22-DE (EUCTR) | 23/10/2006 | 18/09/2006 | Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers | Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers | Primary Biliary Cirrhosis Stage I-III MedDRA version: 12.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® 500 mg Filmtabletten Product Name: Ursofalk® 500 mg Filmtabletten INN or Proposed INN: Ursodeoxycholic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany | |||
| 68 | 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 | NCT04309773 (ClinicalTrials.gov) | March 2020 | 18/10/2019 | Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy | Double Blind, Multicentric, Randomized, Placebo-controlled Trial, Evaluating the Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy | Primary Sclerosing Cholangitis;Cholestasis | Drug: Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy;Drug: Placebo of Bezafibrate in addition to standard UDCA therapy | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 18 Years | 75 Years | All | 104 | Phase 3 | France |
| 3 | NCT03516006 (ClinicalTrials.gov) | January 2017 | 20/9/2017 | Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: UCMSC;Drug: UDCA | Fuzhou General Hospital | NULL | Active, not recruiting | 18 Years | 65 Years | All | 20 | Phase 1;Phase 2 | NULL |
| 4 | 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 | |||
| 5 | 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 |
| 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 | 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 |
| 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 | NCT03724175 (ClinicalTrials.gov) | August 26, 2019 | 12/10/2018 | The Role of Secondary Bile Acids in Intestinal Inflammation | The Role of Secondary Bile Acids in Intestinal Inflammation | Ulcerative Colitis;Pouchitis | Drug: ursodiol (ursodeoxycholic acid, UDCA) | Stanford University | NULL | Recruiting | 18 Years | 70 Years | All | 15 | Phase 2;Phase 3 | United States |
| 2 | EUCTR2009-010921-38-NL (EUCTR) | 08/09/2009 | 02/03/2009 | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Ulcerative Colitis and the risk of developing colorectal cancer. MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Salofalk INN or Proposed INN: mesalazine Trade Name: Ursofalk INN or Proposed INN: ursodeoxycholic acid | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands |
| 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 | ChiCTR1800015250 | 2018-01-01 | 2018-03-19 | The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial | The Effect of Adjuvant UDCA Therapy Post-Kasai Portoenterostomy in Biliary Atresia: a multicenter randomized controlled trial | biliary atresia | high-dose:UDCA 25mg/kg po;low-dose:UDCA 15mg/kg po; | Children's Hospital of Fudan University | NULL | Recruiting | Both | high-dose:100;low-dose:100; | China |