93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2021-001431-56-DE (EUCTR) | 07/03/2022 | 03/11/2021 | Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC | primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norucholic acid (NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid Other descriptive name: norucholic acid | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Finland;Spain;Lithuania;Austria;Switzerland;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands;Norway | ||
| 2 | EUCTR2020-004348-27-DK (EUCTR) | 04/03/2022 | 22/11/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA). MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Denmark;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 3 | NCT05104853 (ClinicalTrials.gov) | January 26, 2022 | 22/10/2021 | Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis | A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA | Primary Biliary Cholangitis | Drug: CNP-104;Drug: Placebo | COUR Pharmaceutical Development Company, Inc. | NULL | Not yet recruiting | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States |
| 4 | NCT04956328 (ClinicalTrials.gov) | July 22, 2021 | 1/7/2021 | Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC) | A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response to UDCA . | Primary Biliary Cirrhosis | Drug: Obeticholic Acid Tablets;Drug: UDCA;Drug: Placebo | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 120 | Phase 3 | China |
| 5 | EUCTR2020-004348-27-DE (EUCTR) | 07/07/2021 | 07/01/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;New Zealand | ||
| 6 | EUCTR2020-004348-27-NL (EUCTR) | 08/06/2021 | 16/03/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 7 | ChiCTR2100046346 | 2021-06-01 | 2021-05-14 | A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis | A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis | primary biliary cholangitis | Ursodeoxycholic acid group:Ursodeoxycholic acid;Rifaximin group :UDCA and rifaximin; | Xiangya Hospital of Central South University | NULL | Recruiting | 18 | 75 | Both | Ursodeoxycholic acid group:30;Rifaximin group :30; | N/A | China |
| 8 | NCT04620733 (ClinicalTrials.gov) | April 21, 2021 | 4/11/2020 | RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) | RESPONSE: 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 | Recruiting | 18 Years | 75 Years | All | 180 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;United Kingdom |
| 9 | EUCTR2019-004941-34-IT (EUCTR) | 13/04/2021 | 04/06/2021 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid - NA | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: [GFT505] | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany | ||
| 10 | NCT04618575 (ClinicalTrials.gov) | March 17, 2021 | 31/10/2020 | Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1 | A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1 | Hepatitis;Primary Biliary Cholangitis;Autoimmune | Drug: Ursodeoxycholic acid combined with total glucosides of paeony;Drug: Ursodeoxycholic acid only | West China Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 137 | Phase 4 | China |
| 11 | EUCTR2020-004348-27-PL (EUCTR) | 16/03/2021 | 02/02/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 12 | EUCTR2020-004348-27-HU (EUCTR) | 04/03/2021 | 20/01/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 13 | EUCTR2020-004348-27-IT (EUCTR) | 16/02/2021 | 24/05/2021 | 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). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary 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). MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: [MBX-8025] INN or Proposed INN: seladelpar Product Name: Seladelpar Product Code: [MBX-8025] INN or Proposed INN: seladelpar | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 14 | EUCTR2018-002575-17-DE (EUCTR) | 09/12/2020 | 30/09/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 15 | EUCTR2019-004941-34-FR (EUCTR) | 30/11/2020 | 09/10/2020 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: ELAFIBRANOR | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany | ||
| 16 | NCT04617561 (ClinicalTrials.gov) | November 1, 2020 | 29/10/2020 | Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II | Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II:A Randomized Controlled Open-label Clinical Trial | Hepatitis, Autoimmune;Primary Biliary Cholangitis | Drug: Ursodeoxycholic acid;Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) | West China Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 90 | Phase 4 | China |
| 17 | EUCTR2019-004941-34-BE (EUCTR) | 09/10/2020 | 31/08/2020 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: ELAFIBRANOR | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany | ||
| 18 | NCT04751188 (ClinicalTrials.gov) | October 2, 2020 | 5/2/2021 | A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis | Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response | Primary Biliary Cirrhosis | Drug: Bezafibrate 200 MG Oral Tablet;Drug: Placebo;Drug: Ursodeoxycholic Acid | Instituto Mexicano del Seguro Social | NULL | Active, not recruiting | 18 Years | 65 Years | All | 11 | Phase 3 | Mexico |
| 19 | NCT04526665 (ClinicalTrials.gov) | September 24, 2020 | 21/8/2020 | Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) | A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: Elafibranor 80mg;Drug: Placebo | Genfit | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;Chile;France;Germany;Italy;South Africa;Spain;Switzerland;Turkey;United Kingdom |
| 20 | EUCTR2018-004011-44-GB (EUCTR) | 10/08/2020 | 28/05/2020 | Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study | A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritus. - TURRIFIC Protocol Version 8 | Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin. MedDRA version: 20.1;Level: PT;Classification code 10049055;Term: Cholestasis of pregnancy;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 20.1;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Product Name: Rifampicin INN or Proposed INN: Rifampicin Product Name: Ursodeoxycholic acid INN or Proposed INN: Ursodeoxycholic acid | The University Of Adelaide | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 108 | Phase 3 | Finland;Australia;Netherlands;United Kingdom;Sweden | ||
| 21 | EUCTR2018-002575-17-AT (EUCTR) | 20/07/2020 | 07/04/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 22 | NCT03954327 (ClinicalTrials.gov) | June 29, 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. | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Canada |
| 23 | EUCTR2018-002575-17-HR (EUCTR) | 05/06/2020 | 25/06/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 24 | EUCTR2018-004011-44-FI (EUCTR) | 20/05/2020 | 26/09/2019 | Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study | A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritis. - TURRIFIC | Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin.;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Product Name: Rifampicin Product Name: Ursodeoxycholic acid | The University of Adelaide | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 108 | Phase 4 | Finland;Australia;Netherlands;United Kingdom;Sweden | ||
| 25 | EUCTR2018-002575-17-PL (EUCTR) | 05/05/2020 | 09/01/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 26 | NCT04650243 (ClinicalTrials.gov) | March 21, 2020 | 27/4/2020 | Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary Cholangitis | Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: ursodeoxycholic acid | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 90 | Phase 4 | China |
| 27 | EUCTR2018-002575-17-CZ (EUCTR) | 27/02/2020 | 16/10/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 28 | EUCTR2018-002575-17-GB (EUCTR) | 14/02/2020 | 19/08/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 29 | EUCTR2018-002575-17-GR (EUCTR) | 14/02/2020 | 05/11/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 30 | 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 |
| 31 | EUCTR2018-002575-17-LT (EUCTR) | 17/01/2020 | 17/10/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 32 | EUCTR2018-002575-17-SK (EUCTR) | 04/12/2019 | 20/09/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 33 | 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 | |
| 34 | 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 | |
| 35 | EUCTR2018-002575-17-ES (EUCTR) | 15/10/2019 | 26/07/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary BiliaryCholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | Estonia;Slovakia;Greece;Spain;Ireland;Israel;France;Denmark;Australia;Latvia;Netherlands;Korea, Republic of;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Poland;Croatia;Germany;Norway;Sweden | ||
| 36 | EUCTR2018-002575-17-FR (EUCTR) | 14/10/2019 | 09/07/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid 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] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Norway;Sweden;Lithuania;Finland;Slovenia;Korea, Republic of;Netherlands;Latvia;Australia;Denmark;France;Israel;Ireland;Spain;Greece;Slovakia;Estonia | ||
| 37 | NCT04594694 (ClinicalTrials.gov) | October 2, 2019 | 14/7/2020 | Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Patients With PBC | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis | Drug: Obeticholic acid;Drug: Bezafibrate 200 MG;Drug: OCA Placebo;Drug: Bezafibrate 200 mg Placebo;Drug: Bezafibrate 400 MG;Drug: Bezafibrate 400 mg Placebo | Intercept Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 75 | Phase 2 | Australia;Austria;Belgium;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Lithuania;Netherlands;Norway;Poland;Spain;Sweden;United Kingdom |
| 38 | NCT04076527 (ClinicalTrials.gov) | September 19, 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 | Recruiting | 18 Years | N/A | All | 1200 | Germany | |
| 39 | EUCTR2018-002575-17-HU (EUCTR) | 25/07/2019 | 04/06/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid 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] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Greece;Finland;Spain;Ireland;Austria;Israel;United Kingdom;France;Hungary;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 40 | 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] | Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 52 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Italy;United Kingdom | ||
| 41 | EUCTR2018-001171-20-AT (EUCTR) | 29/04/2019 | 19/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 42 | EUCTR2018-003365-34-IT (EUCTR) | 18/04/2019 | 03/08/2021 | 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. - na | 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] | Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] Other descriptive name: baricitinib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | United States;United Kingdom;Italy | ||
| 43 | EUCTR2018-001171-20-NL (EUCTR) | 18/04/2019 | 16/11/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;United States;Greece;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 44 | 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 |
| 45 | EUCTR2018-001171-20-BE (EUCTR) | 06/03/2019 | 29/01/2019 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 46 | EUCTR2018-001171-20-FR (EUCTR) | 23/01/2019 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | EUCTR2018-001171-20-ES (EUCTR) | 21/12/2018 | 18/01/2019 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 50 | EUCTR2018-001171-20-DE (EUCTR) | 20/12/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 51 | 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 | ||
| 52 | 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 | ||
| 53 | EUCTR2018-001171-20-HU (EUCTR) | 26/11/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Korea, Republic of;Germany;Netherlands;Romania;Brazil;Belgium | ||
| 54 | EUCTR2018-001171-20-GR (EUCTR) | 23/11/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 55 | EUCTR2018-001171-20-IT (EUCTR) | 08/11/2018 | 17/06/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate thesafety and efficacy of seladelpar in subjects with primary biliary cholangitis(PBC) and an inadequate response to or intolerance to ursodeoxycholicacid (UDCA). - NA | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) andaccumulation of toxic bile acids (BA). MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: seladelpar Product Code: [MXB-8025] INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: [MBX-8025] INN or Proposed INN: seladelpar | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of;Serbia;United States;Greece;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil | ||
| 56 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Australia;Austria;Netherlands;Germany;United Kingdom | ||
| 57 | NCT03602560 (ClinicalTrials.gov) | October 1, 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 | Completed | 18 Years | 75 Years | All | 265 | 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 |
| 58 | 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 | ||
| 59 | 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 | ||
| 60 | EUCTR2016-003817-80-FR (EUCTR) | 09/05/2018 | 08/03/2018 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid | Primary biliary cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor | Genfit SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;France;Spain;Germany;United Kingdom | ||
| 61 | 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 |
| 62 | EUCTR2016-004599-23-IT (EUCTR) | 26/02/2018 | 07/01/2021 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess theEfficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase - GSN00300 | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 | GENKYOTEX SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 63 | NCT03665519 (ClinicalTrials.gov) | January 3, 2018 | 6/9/2018 | Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis | Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis | Primary Biliary Cirrhosis | Dietary Supplement: Sublimated mare milk;Drug: Ursodeoxycholic Acid | National Scientific Medical Center, Kazakhstan | Eurasia Invest Ltd.;Ministry of Education and Science, Republic of Kazakhstan | Completed | 18 Years | 75 Years | All | 40 | N/A | Kazakhstan |
| 64 | 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 |
| 65 | EUCTR2016-004599-23-GR (EUCTR) | 27/10/2017 | 06/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 66 | EUCTR2016-004599-23-DE (EUCTR) | 19/09/2017 | 10/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 67 | EUCTR2016-004599-23-BE (EUCTR) | 10/08/2017 | 10/04/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 68 | EUCTR2016-004599-23-ES (EUCTR) | 26/07/2017 | 04/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 69 | EUCTR2016-004599-23-GB (EUCTR) | 30/06/2017 | 17/05/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 70 | NCT03226067 (ClinicalTrials.gov) | June 26, 2017 | 30/6/2017 | Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid. | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase | Primary Biliary Cirrhosis | Drug: GKT137831;Drug: Placebo oral capsule | Genkyotex SA | NULL | Completed | 18 Years | 80 Years | All | 111 | Phase 2 | United States;Belgium;Canada;Germany;Greece;Israel;Italy;Spain;United Kingdom |
| 71 | EUCTR2016-003817-80-GB (EUCTR) | 31/05/2017 | 08/03/2017 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | Primary biliary cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor | Genfit SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Spain;Germany;United Kingdom | ||
| 72 | NCT03092765 (ClinicalTrials.gov) | May 29, 2017 | 24/3/2017 | Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid | A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid | Primary Biliary Cholangitis | Drug: E6011;Drug: Placebo | EA Pharma Co., Ltd. | NULL | Terminated | 20 Years | 74 Years | All | 29 | Phase 2 | Japan |
| 73 | EUCTR2016-003817-80-ES (EUCTR) | 22/05/2017 | 08/03/2017 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | Primary biliary cholangitis MedDRA version: 19.1;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor | Genfit SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | France;United States;Spain;Germany;United Kingdom | ||
| 74 | NCT03188146 (ClinicalTrials.gov) | May 1, 2017 | 8/6/2017 | Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid | Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) | Drug: Ursodeoxycholic Acid | Humanity and Health Research Centre | Beijing 302 Hospital | Recruiting | 18 Years | 85 Years | All | 500 | China | |
| 75 | NCT03124108 (ClinicalTrials.gov) | April 5, 2017 | 28/3/2017 | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) | Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo | Genfit | NULL | Completed | 18 Years | 75 Years | All | 45 | Phase 2 | United States;France;Germany;Spain;United Kingdom |
| 76 | EUCTR2016-002996-91-DE (EUCTR) | 21/02/2017 | 17/11/2016 | A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 77 | EUCTR2016-002996-91-GB (EUCTR) | 12/01/2017 | 21/11/2016 | A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 78 | NCT02936596 (ClinicalTrials.gov) | December 2016 | 15/10/2016 | Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome | Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents | Hepatitis, Autoimmune;Cholangitis;Liver Cirrhosis, Biliary;Cholestasis | Drug: Ursodeoxycholic acid combination of immunosuppressive agents;Drug: Ursodeoxycholic Acid | Xiaoli Fan | NULL | Recruiting | 18 Years | 75 Years | All | 53 | N/A | China |
| 79 | NCT03489889 (ClinicalTrials.gov) | December 2016 | 12/1/2018 | Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine | Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine | Ursodeoxycholic Acid;Primary Biliary Cirrhosis | Drug: Ursodeoxycholic Acid 300mg tablet;Drug: Ursodeoxycholic Acid 300mg capsule | University of Sao Paulo General Hospital | NULL | Completed | 18 Years | N/A | All | 30 | N/A | Brazil |
| 80 | 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 |
| 81 | NCT02937012 (ClinicalTrials.gov) | October 2016 | 13/10/2016 | Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders | Efficacy and Security of Bezafibrate in Patients With Primary Biliary Cirrhosis Without Biochemical Response to Ursodeoxycholic Acid: A Randomized, Double-blind, Placebo-controlled Trial | Primary Biliary Cirrhosis | Drug: Bezafibrate;Drug: Ursodeoxycholic Acid;Drug: Placebo (for Bezafibrate) | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | NULL | Unknown status | 18 Years | 65 Years | All | 34 | Phase 3 | Mexico |
| 82 | 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 | |
| 83 | 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 | ||
| 84 | 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 | |
| 85 | 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 | |
| 86 | 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 | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 1/Phase 2 | China |
| 87 | 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 |
| 88 | 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 | |
| 89 | 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 | ||
| 90 | 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 | ||
| 91 | 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 |
| 92 | NCT02078882 (ClinicalTrials.gov) | September 2014 | 3/3/2014 | Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis | Abatacept For The Treatment Of Primary Biliary Cirrhosis With An Incomplete Biochemical Response To Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Biological: abatacept | Christopher Bowlus, MD | Bristol-Myers Squibb | Completed | 18 Years | N/A | All | 16 | Phase 4 | United States |
| 93 | NCT01899703 (ClinicalTrials.gov) | March 10, 2014 | 3/7/2013 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of GSK2330672 Administration in Patients With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus | Cholestasis, Intrahepatic | Drug: GSK2330672;Drug: Placebo;Drug: Ursodeoxycholic acid | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 22 | Phase 2 | United Kingdom |
| 94 | 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 |
| 95 | 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 |
| 96 | 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 | ||
| 97 | 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 | ||
| 98 | NCT01654731 (ClinicalTrials.gov) | October 15, 2012 | 30/7/2012 | Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Multicenter, Randomized, Double-blind Placebo Controlled Trial of Bezafibrate for the Treatment of Primary Biliary Cirrhosis in Patients With Incomplete Response to Ursodesoxycholic Acid Therapy. | PBC | Drug: Bezafibrate;Drug: placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | France |
| 99 | NCT01430429 (ClinicalTrials.gov) | December 2011 | 5/9/2011 | Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an 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 PBC Patients With an Incomplete Response to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: NI-0801 | NovImmune SA | NULL | Terminated | 18 Years | N/A | Both | Phase 2 | Italy;United Kingdom | |
| 100 | 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 | ||||
| 101 | NCT01440309 (ClinicalTrials.gov) | November 2011 | 20/9/2011 | Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis | Phase I Clinical Trial, Randomized, Controlled, to Evaluate the Efficacy and Safety of Therapy With Allogenic Mesenchymal Stem Cells From Bone Marrow for Patients With Refractory Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Biological: Biological: mesenchymal stem cell;Drug: ursodeoxycholic acid | Robert Chunhua Zhao, MD, PhD | Peking Union Medical College Hospital | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 1 | China |
| 102 | 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 | ||
| 103 | 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 | ||
| 104 | 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 |
| 105 | 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 | |||
| 106 | EUCTR2011-001326-26-GB (EUCTR) | 27/05/2011 | 24/03/2011 | Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody. | PIANO. 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 | Primary biliary cirrhosis MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: NI-0801 Other descriptive name: fully human monoclonal antibody directed against CXCL10 | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | Italy;United Kingdom | ||||
| 107 | 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 |
| 108 | NCT01857284 (ClinicalTrials.gov) | September 2009 | 16/5/2013 | Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis | A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Tauroursodeoxycholic Acid Capsules;Drug: Ursodeoxycholic Acid Capsules | Beijing Friendship Hospital | Beijing Trendful Kangjian Medical Information Consulting Limited Company | Completed | 18 Years | 70 Years | Both | 216 | Phase 3 | China |
| 109 | EUCTR2007-004040-70-GB (EUCTR) | 01/06/2009 | 19/08/2008 | 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 | 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 | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | 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 | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 110 | EUCTR2007-004040-70-IT (EUCTR) | 20/05/2009 | 22/05/2009 | 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 | 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 | Patients with PBC and with risk of a progression of this disease. MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budesonide INN or Proposed INN: Budesonide Trade Name: acido ursodessicolico INN or Proposed INN: Ursodeoxycholic acid | DR. FALK PHARMA GMBH | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | Sweden;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Poland;Denmark;Germany;Netherlands | ||
| 111 | EUCTR2007-004040-70-AT (EUCTR) | 19/03/2009 | 23/06/2008 | 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 | 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 | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | 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 | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 112 | 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 | |||
| 113 | 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 | |||
| 114 | NCT00746486 (ClinicalTrials.gov) | February 2009 | 3/9/2008 | Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC) | 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 | Primary Biliary Cirrhosis | Drug: budesonide;Drug: budesonide placebo | Dr. Falk Pharma GmbH | NULL | Terminated | 18 Years | N/A | All | 62 | Phase 3 | France;Germany |
| 115 | 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 | ||
| 116 | 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 | |||
| 117 | 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 | ||
| 118 | EUCTR2008-001524-31-NL (EUCTR) | 26/11/2008 | 17/07/2008 | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | ||
| 119 | 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 | ||
| 120 | 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 |
| 121 | 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 | ||
| 122 | 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 | |||
| 123 | EUCTR2007-004040-70-ES (EUCTR) | 01/10/2008 | 01/08/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(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 | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(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 | Pacientes con cirrosis biliar primaria con riesgo de progresíon de la enfermedadPatients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | 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 | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 124 | 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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 125 | 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 | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 126 | 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 | ||
| 127 | EUCTR2007-004040-70-FR (EUCTR) | 09/09/2008 | 09/06/2008 | 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 | 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 | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden | ||
| 128 | EUCTR2008-001524-31-DE (EUCTR) | 26/08/2008 | 11/07/2008 | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | ||
| 129 | 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 | ||
| 130 | 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 | ||
| 131 | 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 |
| 132 | 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 | |||
| 133 | 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 | |
| 134 | NCT00004784 (ClinicalTrials.gov) | January 1994 | 24/2/2000 | Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: methotrexate;Drug: ursodiol | National Center for Research Resources (NCRR) | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);University of Texas | Completed | 20 Years | 69 Years | Both | 315 | Phase 3 | NULL | |
| 135 | NCT00006168 (ClinicalTrials.gov) | January 1994 | 8/8/2000 | Ursodiol-Methotrexate for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: Methotrexate | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 20 Years | 69 Years | Both | Phase 3 | United States | ||
| 136 | NCT00004748 (ClinicalTrials.gov) | November 1989 | 24/2/2000 | Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: colchicine;Drug: methotrexate;Drug: ursodiol | National Center for Research Resources (NCRR) | Tufts Medical Center | Completed | N/A | N/A | Both | 90 | Phase 3 | NULL |