93. 原発性胆汁性胆管炎 ［臨床試験数：114，薬物数：136（DrugBank：42），標的遺伝子数：27，標的パスウェイ数：78］
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03954327 | February 2020 | 14 October 2019 | Combination Antiretroviral Therapy (cART) for PBC | Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: Emtricitabine (FTC)/Tenofovir Disoproxil (TDF);Drug: Raltegravir;Drug: Placebo Oral Capsule [CEBOCAP] | University of Alberta | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 60 | Phase 2 | Canada |
| 2 | NCT04076527 | September 2019 | 16 September 2019 | Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis | Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis | PBC;Primary Biliary Cholangitis | Drug: UDCA;Drug: Ocaliva | University of Leipzig | RWTH Aachen University;Zentrum für Klinische Studien Leipzig;Intercept Pharma Europe Limited (IPEL);Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);University Hospital Erlangen;Medical care center for Gastroenterology, Berlin;Institute for Interdisciplinary Medicine, Hamburg;Leberhilfe Projekt gUG, Cologne;Hannover Medical School | Not recruiting | 18 Years | N/A | All | 1200 | N/A | Germany |
| 3 | NCT04047160 | August 29, 2019 | 30 September 2019 | Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I) | A Single-Center, Open-Label, Dose-Escalation Study of Cyclic Adenosine Monophosphate (AMP)-Response Element-binding (CREB)-Binding Protein (CBP) / ß-Catenin Inhibitor OP-724 in Patients With Primary Biliary Cholangitis (Phase I) | Primary Biliary Cholangitis (PBC);Liver Cirrhosis, Biliary | Drug: OP-724 | Komagome Hospital | OHARA Pharmaceutical Co., Ltd.;Japan Agency for Medical Research and Development | Recruiting | 20 Years | 74 Years | All | 12 | Phase 1 | Japan |
| 4 | NCT03995212 | June 25, 2019 | 11 November 2019 | Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus | A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus | Cholestatic Pruritus | Drug: CR845 1.0 mg;Drug: Placebo | Cara Therapeutics, Inc. | Recruiting | 18 Years | 80 Years | All | 60 | Phase 2 | United States | |
| 5 | NCT03742973 | March 28, 2019 | 4 November 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 | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | Not recruiting | 18 Years | N/A | All | 2 | Phase 2 | United States;Puerto Rico;Italy;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2017-003528-62-BE | 11/01/2019 | 30 April 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: EDP-305 Product Code: EDP-305 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Enanta Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | |||
| 7 | ChiCTR1800020160 | 2018-12-20 | 14 January 2019 | Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis | Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis | Primary Biliary Cirrhosis | 1:Fenofibrate+UDCA;2:UDCA; | Peking Union Medical College Hosipital | Recruiting | 18 | 65 | Both | 1:20;2:20; | Pilot study | China | |
| 8 | EUCTR2018-001171-20-DE | 20/12/2018 | 28 February 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 Pharmaceutical Form: Capsule INN or Proposed INN: SELADELPAR CAS Number: 928821-40-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Seladelpar Product Code: MBX-8025 Pharmaceutical Form: Capsule INN or Proposed INN: SELADELPAR CAS Number: 928821-40-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | CymaBay Therapeutics, Inc. | Authorised | Female: yes Male: yes | 240 | Phase 3 | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | |||
| 9 | EUCTR2017-003528-62-DE | 05/12/2018 | 30 April 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: EDP-305 Product Code: EDP-305 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Enanta Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | |||
| 10 | EUCTR2017-003528-62-NL | 29/11/2018 | 28 February 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: EDP-305 Product Code: EDP-305 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Enanta Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Germany;Netherlands;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03602560 | November 26, 2018 | 28 October 2019 | 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. | Recruiting | 18 Years | 75 Years | All | 240 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;United Kingdom | |
| 12 | EUCTR2017-001762-13-BE | 24/10/2018 | 7 January 2019 | A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body. | A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment | Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Intercept Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 50 | Phase 3;Phase 4 | United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany | |||
| 13 | EUCTR2017-003528-62-ES | 28/08/2018 | 3 September 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 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: EDP-305 Product Code: EDP-305 Pharmaceutical Form: Tablet INN or Proposed INN: EDP-305 CAS Number: 1933507-63-1 Current Sponsor code: EDP-305 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Enanta Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | |||
| 14 | EUCTR2017-001762-13-ES | 01/08/2018 | 20 August 2018 | A clinical trial where neither the doctor, patient or sponsor know whether a placebo or active medicine is being given to the patient with cirrhosis to see if the medicine is safe in the treatment of that disease and to see how study drug is absorbed, distributed through the body and excreted out of the body. | A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment | Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA Pharmaceutical Form: Tablet INN or Proposed INN: obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Intercept Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 50 | Phase 4 | United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany | |||
| 15 | NCT03521297 | July 20, 2018 | 16 July 2018 | Curative Effect Observation of UDCA Combined Probiotics Therapy in PBC of Poor Response to UDCA | The Comparison of Curative Effects of UDCA Combined Probiotics With Single UDCA Therapy in Primary Biliary Cholangitis of Poor Response to UDCA: A Randomized Controlled Trial | Primary Biliary Cholangitis | Drug: UDCA combined probiotics | Sun Yat-sen University | Not recruiting | 30 Years | 70 Years | All | 40 | Phase 1/Phase 2 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03476993 | April 27, 2018 | 22 October 2019 | 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 | Not recruiting | 18 Years | 60 Years | All | 9 | Phase 2 | Russian Federation | |
| 17 | JPRN-UMIN000031384 | 2018/03/16 | 2 April 2019 | Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) | PBC patients with osteoporosis | Denosumab group (60 mg Denosumab is administered subcutaneously every 6 month) Zoledronic acid group (5 mg Zoledronic acid is administered intravenously every 12 month) | Tokai University School of Medicine | Ministry of Health, Labour and Welfare | Recruiting | 20years-old | 89years-old | Male and Female | 80 | Not selected | Japan | |
| 18 | NCT03345589 | January 30, 2018 | 11 June 2018 | A Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis | A Randomized Controlled Trial of 18-22mg/kg/d Ursodeoxycholic in Refractory Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: 18-22mg/kg/d Ursodeoxycholic;Drug: 13-15mg/kg/d Ursodeoxycholic | West China Hospital | Recruiting | 18 Years | 70 Years | All | 40 | Phase 4 | China | |
| 19 | NCT03665519 | January 3, 2018 | 17 September 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 | Drug: Ursodeoxycholic Acid;Dietary Supplement: Sublimated mare milk | National Scientific Medical Center, Kazakhstan | Eurasia Invest Ltd., Kazakhstan;Ministry of education and science Republic of Kazakhstan | Recruiting | 18 Years | 75 Years | All | 40 | N/A | Kazakhstan |
| 20 | NCT03394924 | December 27, 2017 | 26 August 2019 | 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 | Recruiting | 18 Years | 75 Years | All | 119 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03155932 | December 15, 2017 | 27 May 2019 | Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Patients With Primary Biliary Cholangitis | An Open-label, Pilot, Proof of Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Etrasimod (APD334) in Patients With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: APD334 | Arena Pharmaceuticals | Not recruiting | 18 Years | 80 Years | All | 2 | Phase 2 | United States;Australia;New Zealand | |
| 22 | NCT03301506 | December 12, 2017 | 28 October 2019 | Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) | An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) | Primary Biliary Cirrhosis | Drug: Seladelpar 2 mg Capsule;Drug: Seladelpar 5 mg Capsule;Drug: Seladelpar 10 mg Capsule | CymaBay Therapeutics, Inc. | Recruiting | 18 Years | 75 Years | All | 356 | Phase 2/Phase 3 | United States;Canada;Germany;United Kingdom | |
| 23 | EUCTR2014-001438-27-ES | 29/11/2017 | 5 June 2018 | The effect of bezafibrate on itch in a subset of liver diseases | The effect of bezafibrate on cholestatic itch - FITCH | Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezalip Pharmaceutical Form: Coated tablet INN or Proposed INN: BEZAFIBRATE CAS Number: 41859-67-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Academic Medical Center | Authorised | Female: yes Male: yes | 84 | Phase 2 | Spain;Netherlands | |||
| 24 | EUCTR2016-004599-23-DE | 19/09/2017 | 30 April 2019 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: GKT137831 CAS Number: 1218942-37-0 Other descriptive name: GKT137831 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Genkyotex SA | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | |||
| 25 | NCT03112681 | August 18, 2017 | 22 July 2019 | Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis | A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS ) | Primary Biliary Cirrhosis | Drug: Saroglitazar magnesium 2 mg;Drug: Saroglitazar magnesium 4 mg;Drug: Placebo Oral Tablet | Zydus Discovery DMCC | Recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2016-004599-23-ES | 26/07/2017 | 21 August 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 Pharmaceutical Form: Capsule INN or Proposed INN: GKT137831 CAS Number: 1218942-37-0 Other descriptive name: GKT137831 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Genkyotex SA | Authorised | Female: yes Male: yes | 102 | Phase 2 | United Kingdom;Italy;Germany;Israel;Spain;Belgium;Canada;Greece;United States | |||
| 27 | EUCTR2016-002965-67-NL | 07/07/2017 | 17 July 2017 | A study on the effect of obetihcolic acid on bile composition in patients with PBC (chronic liver disease of the small bile ducts), NASH (chronic liver disease as a result of fatty liver) and healthy volunteers | An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILE | Primary biliairy cholangitis (PBC) Non-alcoholic steatohepatitis (NASH) MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA (INT-747) Product Code: OCA (INT-747) Pharmaceutical Form: Tablet | AMC | Authorised | Female: yes Male: yes | Phase 2 | Netherlands | ||||
| 28 | NCT03226067 | June 26, 2017 | 22 October 2019 | 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: Placebo oral capsule;Drug: GKT137831 | Genkyotex SA | Not recruiting | 18 Years | 80 Years | All | 111 | Phase 2 | United States;Belgium;Canada;Germany;Greece;Israel;Italy;Spain;United Kingdom | |
| 29 | EUCTR2016-003817-80-GB | 31/05/2017 | 28 February 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Elafibranor CAS Number: 824932-88-9 Current Sponsor code: GFT505 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Elafibranor Product Code: GFT505 Pharmaceutical Form: Tablet INN or Proposed INN: Elafibranor CAS Number: 824932-88-9 Current Sponsor code: GFT505 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Genfit SA | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | France;United States;Spain;Germany;United Kingdom | |||
| 30 | NCT03092765 | May 29, 2017 | 14 January 2019 | 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. | Not recruiting | 20 Years | 74 Years | All | 29 | Phase 2 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT03188146 | May 1, 2017 | 11 March 2019 | 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 | Phase 3 | China |
| 32 | NCT03124108 | April 5, 2017 | 7 October 2019 | 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 | Not recruiting | 18 Years | 75 Years | All | 45 | Phase 2 | United States;France;Germany;Spain;United Kingdom | |
| 33 | EUCTR2016-002996-91-DE | 21/02/2017 | 3 September 2018 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: Seladelpar Product Code: MBX-8025 Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 928821-40-3 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: Seladelpar Product Code: MBX-8025 Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: Seladelpar Product Code: MBX-8025 Pharmaceutical Form: Capsule, hard INN or Proposed INN: NA CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | CymaBay Therapeutics, Inc. | Authorised | Female: yes Male: yes | 128 | Phase 2 | United States;Canada;Germany;United Kingdom | |||
| 34 | EUCTR2016-002416-41-ES | 17/02/2017 | 13 March 2017 | Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cholangitis – The GLIMMER Study | A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis. (GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response). | Primary biliary cholangitis (PBC) MedDRA version: 19.0 Level: PT Classification code 10008604 Term: Cholangitis System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 19.0 Level: PT Classification code 10037087 Term: Pruritus System Organ Class: 10040785 - Skin and subcutaneous tissue disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: GSK2330672 Product Code: GSK2330672 Pharmaceutical Form: Tablet INN or Proposed INN: GSK2330672 CAS Number: 1345983-37-0 Current Sponsor code: GSK2330672 Other descriptive name: GSK2330672 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: GSK2330672 Product Code: GSK2330672 Pharmaceutical Form: Tablet INN or Proposed INN: GSK2330672 CAS Number: 1345983-37-0 Current Sponsor code: GSK2330672 Other descriptive name: GSK2330672 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | GlaxoSmithKline, S.A. | Authorised | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Spain;Australia;Netherlands;Japan;United Kingdom | |||
| 35 | NCT03082937 | January 31, 2017 | 16 December 2017 | An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects | An Open Label, Single-Dose, Single Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-A4250 in Healthy Male Subjects | Orphan Cholestatic Liver Diseases;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome;Primary Biliary Cirrhosis | Drug: 3 mg [14C]-A4250 capsule | Albireo | Not recruiting | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | EUCTR2016-002996-91-GB | 12/01/2017 | 28 February 2019 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Seladelpar CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: Seladelpar Product Code: MBX-8025 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Seladelpar CAS Number: 928821-40-3 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: Seladelpar Product Code: MBX-8025 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Seladelpar CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: Seladelpar Product Code: MBX-8025 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Seladelpar CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | CymaBay Therapeutics, Inc. | Authorised | Female: yes Male: yes | 128 | Phase 2 | United States;Canada;Germany;United Kingdom | |||
| 37 | NCT02966834 | January 11, 2017 | 4 November 2019 | Dose Response Study of GSK2330672 for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis | A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response) | Cholestasis | Drug: Placebo;Drug: GSK2330672 | GlaxoSmithKline | Not recruiting | 18 Years | 80 Years | All | 140 | Phase 2 | United States;Australia;Canada;France;Germany;Italy;Japan;Poland;Spain;United Kingdom | |
| 38 | NCT02943447 | December 1, 2016 | 30 September 2019 | Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis | A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Primary Biliary Cholangitis Without Cirrhosis | Primary Biliary Cholangitis | Drug: Cilofexor;Drug: Placebo to match Cilofexor | Gilead Sciences | Not recruiting | 18 Years | 70 Years | All | 71 | Phase 2 | United States;Austria;Canada;United Kingdom | |
| 39 | NCT02936596 | December 2016 | 4 March 2019 | 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 | Recruiting | 18 Years | 75 Years | All | 53 | N/A | China | |
| 40 | NCT03489889 | December 2016 | 22 October 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 | Not recruiting | 18 Years | N/A | All | 30 | N/A | Brazil | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT02955602 | November 28, 2016 | 2 July 2018 | 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 10 mg Capsule;Drug: MBX-8025 5 mg Capsule;Drug: MBX-8025 2 mg Capsule | CymaBay Therapeutics, Inc. | Not recruiting | 18 Years | 75 Years | All | 116 | Phase 2 | United States;Canada;Germany;United Kingdom | |
| 42 | NCT02937012 | October 2016 | 11 June 2018 | 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 | Recruiting | 18 Years | 65 Years | All | 34 | Phase 3 | Mexico | |
| 43 | NCT02931513 | September 2016 | 5 November 2018 | 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 | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | Denmark | |
| 44 | NCT03253276 | May 19, 2016 | 11 November 2019 | Effect of Obeticholic Acid on Transport of Bile Acids in PBC Examined by 11C-cholyl-sarcosine PET/CT | Effect of Obeticholic Acid (INT-747, Intercept) on the Hepatobiliary Transport of Bile Acids in Patients With PBC Examined by 11C-cholyl-sarcosine PET/CT | Primary Biliary Cirrhosis | Drug: Obeticholic acid;Drug: Placebos | University of Aarhus | Not recruiting | 18 Years | 85 Years | All | 8 | Early Phase 1 | Denmark | |
| 45 | NCT02701166 | February 2016 | 11 April 2016 | The Effect of Bezafibrate on Cholestatic Itch | The Effect of Bezafibrate on Cholestatic Itch | Primary Biliary Cholangitis;Primary Sclerosing Cholangitis;Secondary Sclerosing Cholangitis | Drug: Bezafibrate;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Erasmus Medical Center;University Medical Center Groningen;Leiden University Medical Center;UMC Utrecht;Radboud University;Maastricht University Medical Center;Free University Medical Center;University of Barcelona;Ludwig-Maximilians - University of Munich;Friedrich-Alexander-Universität Erlange-Nürnberg;Istituto Clinico Humanitas | Recruiting | 18 Years | N/A | Both | 84 | Phase 3 | Netherlands;Spain |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT02823353 | January 2016 | 21 July 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 | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | |
| 47 | NCT02823366 | January 2016 | 21 July 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 | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | ||
| 48 | NCT02916290 | January 2016 | 10 October 2016 | Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Fuzhenghuayu;Drug: UDCA | Xijing Hospital of Digestive Diseases | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | ||
| 49 | NCT02916641 | January 2016 | 10 October 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 | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | ||
| 50 | NCT02965911 | January 2016 | 28 November 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 | Recruiting | 18 Years | 65 Years | Both | 72 | Phase 1/Phase 2 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | EUCTR2015-002698-39-GB | 11/11/2015 | 18 April 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 Pharmaceutical Form: Capsule, hard CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: MBX 8025 Product Code: MBX 8025 Pharmaceutical Form: Capsule, hard CAS Number: 928821-40-3 Current Sponsor code: MBX-8025 Other descriptive name: MBX-8025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | CymaBay Therapeutics Inc. | Authorised | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | |||
| 52 | NCT02557360 | November 2015 | 16 December 2017 | Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis | Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Dietary Supplement: S-adenosyl-L-methionine | Pomeranian Medical University Szczecin | Laval University | Not recruiting | N/A | N/A | All | 24 | Phase 4 | Poland |
| 53 | NCT02516605 | September 9, 2015 | 9 October 2018 | A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients | A Multi-part, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of Tropifexor (LJN452) in Patients With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: Part 1: LJN452;Drug: Part 1: Placebo;Drug: Part 2: LJN452 Dose level 1;Drug: Part 2: Placebo;Drug: Part 2: LJN452 Dose level 2 | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 61 | Phase 2 | United States;Canada;Germany;Poland;Russian Federation;United Kingdom | |
| 54 | EUCTR2014-001438-27-NL | 19/08/2015 | 14 September 2015 | The effect of bezafibrate on itch in a subset of liver diseases | The effect of bezafibrate on cholestatic itch - FITCH | Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezalip Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Academic Medical Center | Authorised | Female: yes Male: yes | 84 | Netherlands | ||||
| 55 | NCT02193360 | May 2015 | 5 September 2016 | Pilot Study of FFP104 Dose Escalation in PBC Subjects | A Phase I/II, Open Label, Multicenter, Pilot Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacodynamics of FFP104 in Subjects Previously Diagnosed With Primary Biliary Cirrhosis (PBC) | Primary Biliary Cirrhosis | Drug: FFP104 | Fast Forward Pharmaceuticals | Recruiting | 18 Years | 75 Years | Both | 24 | Phase 1/Phase 2 | Netherlands;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT02321306 | May 2015 | 1 April 2019 | An Open-label Study to Evaluate the Long-term Safety and Tolerability of LUM001 in Patients With Primary Biliary Cirrhosis | An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Tolerability of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: LUM001 | Mirum Pharmaceuticals, Inc. | Not recruiting | 18 Years | N/A | All | 0 | Phase 2 | United States;United Kingdom | |
| 57 | NCT02360852 | January 2015 | 16 December 2017 | IBAT Inhibitor A4250 for Cholestatic Pruritus | An Exploratory, Phase IIa Study to Demonstrate the Safety and Efficacy of A4250 in Patients With Primary Biliary Cirrhosis and Cholestatic Pruritus | Biliary Cirrhosis, Primary | Drug: A4250 | Sahlgrenska University Hospital, Sweden | Albireo | Not recruiting | 18 Years | 80 Years | All | 9 | Phase 2 | Sweden |
| 58 | EUCTR2014-004070-42-SE | 09/12/2014 | 6 January 2015 | Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic Pruritus | An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacy and Safety of A4250 in Patients with Primary Biliary Cirrhosis and Cholestatic Pruritus | Primary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: A4250 Pharmaceutical Form: Capsule | Sahlgrenska Academy | Authorised | Female: yes Male: yes | Phase 2a | Sweden | ||||
| 59 | NCT02308111 | December 2014 | 22 October 2019 | Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis | A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis | Liver Cirrhosis, Biliary | Drug: Obeticholic Acid (OCA);Drug: Placebo | Intercept Pharmaceuticals | Recruiting | 18 Years | N/A | All | 428 | Phase 4 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Serbia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Former Serbia and Montenegro | |
| 60 | NCT02078882 | September 2014 | 22 October 2018 | 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 | Not recruiting | 18 Years | N/A | All | 16 | Phase 4 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT02135536 | May 2014 | 16 December 2017 | Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis | A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103 | Primary Biliary Cirrhosis | Biological: NGM282 | NGM Biopharmaceuticals, Inc | NGM Biopharmaceuticals Australia Pty Ltd | Not recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Australia;New Zealand |
| 62 | NCT01899703 | March 10, 2014 | 16 December 2017 | 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 | Not recruiting | 18 Years | 75 Years | All | 22 | Phase 2 | United Kingdom | |
| 63 | JPRN-UMIN000012782 | 2014/02/01 | 2 April 2019 | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Group A; phenylbutyrate 6g (Child 100mg/kg)/day *7days Group B; phenylbutyrate 6g (Child 100mg/kg)/day *3days and 12g (Child 200mg/kg)/day *4days Group C; phenylbutyrate 6g (Child 100mg/kg)/day *1day, phenylbutyrate 12g (Child 200mg/kg)/day *2days and phenylbutyrate 21g (Child 300mg/kg)/day *4days | Juntendo University | Not Recruiting | Not applicable | Not applicable | Male and Female | 2 | Not selected | Japan | ||
| 64 | NCT02026401 | February 2014 | 16 December 2017 | 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 | Not recruiting | 18 Years | 75 Years | All | 45 | Phase 2 | United States;Australia |
| 65 | JPRN-UMIN000012489 | 2013/12/04 | 2 April 2019 | Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis | Osteoporosis in biopsy-proven PBC who was not pretreated with denosumab and/or bisphosphonate in recent 6 months | For osteoporosis patients who need treatment based on PBC treatment guideline, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. PBC patients who do not meet osteoporosis treatment criteria will be followed. | Juntendo University School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | JPRN-UMIN000012193 | 2013/11/01 | 2 April 2019 | Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis | Osteoporosis in biopsy-proven primary biliary cirrhosis patients pretreated with bisphosphonate | Discontinue the administration of aredoron acid, risedronic acid, and minodronic acid. Then, 60mg of denosumab will be subcutaneously injected every 6 months for 12 months. All patients will take activated vitamin D. In the case of hypocalcemia, calcium will be administrated appropriately. Continue the administration of bisphosphonate as heretofore. All patients will take activated vitamin D. | Juntendo University School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not applicable | Japan | ||
| 67 | NCT01865812 | November 2013 | 11 June 2018 | Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis | A Phase 2 Clinical Trial Investigating the Effects of Obeticholic Acid on Lipoprotein Metabolism in Subjects With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: obeticholic acid (OCA) | Intercept Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 26 | Phase 2 | United States | |
| 68 | EUCTR2013-000482-36-GB | 08/07/2013 | 4 August 2015 | 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 fifth to 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 Pharmaceutical Form: Tablet INN or Proposed INN: LUM001 Current Sponsor code: LUM001 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5-20 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Lumena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;United Kingdom | |||
| 69 | NCT02963077 | July 2013 | 28 November 2016 | A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384 | A Phase I, Double-Blind Single and Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of A4250 as Monotherapy, and in Combination With Colonic Release Cholestyramine (A3384) or Commercially Available Cholestyramine (Questran™) in Healthy Subjects | Orphan Cholestatic Liver Diseases;Primary Biliary Cirrhosis;Progressive Familial Intrahepatic Cholestasis;Alagille Syndrome | Drug: A4250;Drug: CRC (A3384);Drug: Questran;Drug: Placebo | Albireo | Not recruiting | 18 Years | 60 Years | Both | 94 | Phase 1 | ||
| 70 | NCT01879735 | June 2013 | 19 October 2017 | Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT | Hepatic Transport of Conjugated Bile Acids in Humans Quantified by 11C-cholylsarcosine PET/CT | Cholestasis;Primary Sclerosing Cholangitis;Primary Biliary Cirrhosis | Drug: 11C-CSar;Drug: ICG | University of Aarhus | Not recruiting | 18 Years | N/A | All | 22 | Phase 1 | Denmark | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | JPRN-UMIN000015789 | 2012/11/30 | 2 April 2019 | Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation | non-compenzated liver cirrhosis(HBV,HCV, alcoholic, etc), primary biliary cirrhosis (PBC), primary screlosing cholangitis (PSC), hepatocellular carcinoma (HCC within Milan criteria), non-alcoholic steatohepatitis (NASH), others | The patient is given cyclophosphamide (40mg/kg,iv) on postoperative days (POD) 5, and ex-vivo generated regulatory T cells on POD 13. Postoperative immunosuppression is with comventioal method. Tke immunosuppressant is reduced to 3/4 daily dose of the twice daily dose at 6 months, which is reduced to 3 times/week, 2 times/ week and 1 time/week every 3 months after confirming normal graft function and liver biopsy. the immunosuppressant is completely discontinued by 18 months after transplantation. | Traslational Research and Clinical Trial Center | Recruiting | 18years-old | 65years-old | Male and Female | 10 | Phase 1,2 | Japan | ||
| 72 | NCT01654731 | October 15, 2012 | 10 September 2018 | 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 | Not recruiting | 18 Years | N/A | All | 100 | Phase 3 | France | |
| 73 | EUCTR2012-000145-12-GB | 15/08/2012 | 30 April 2019 | Pilot study of Rituximab for the treatment of fatigue in PBC | Rituximab for the Treatment of Fatigue in Primary Biliary Cirrhosis (PBC) - RITPBC Study | Severe fatigue in Primary Biliary Cirrhosis MedDRA version: 18.0 Level: PT Classification code 10004661 Term: Biliary cirrhosis primary System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: MabThera® Product Name: MabThera® Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31-7 Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | The Newcastle upon Tyne Hospitals NHS Foundation Trust | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | United Kingdom | |||
| 74 | NCT01614405 | June 2012 | 14 December 2015 | Highly Active Antiretroviral Therapy for Patients With Primary Biliary Cirrhosis | Randomized Controlled Pilot Study of Highly Active Anti-Retroviral Therapy for Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Truvada and Kaletra | University of Alberta | Abbott;Gilead Sciences;Canadian Institutes of Health Research (CIHR) | Not recruiting | 18 Years | N/A | Both | 13 | N/A | Canada |
| 75 | EUCTR2011-004728-36-SE | 16/04/2012 | 30 April 2019 | A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) Pharmaceutical Form: Tablet INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: OCA, 6-ECDCA or INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) Pharmaceutical Form: Tablet INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: OCA, 6-ECDCA or INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Intercept Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | EUCTR2011-004728-36-BE | 30/03/2012 | 30 April 2019 | A study of Obeticholic Acid versus Placebo in Patients with Primary Biliary Cirrhosis plus long term extension study only with Obeticholic Acid | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) Pharmaceutical Form: Tablet INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: OCA, 6-ECDCA or INT-747 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) Pharmaceutical Form: Tablet INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: OCA, 6-ECDCA or INT-747 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Intercept Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 77 | NCT01473524 | January 2012 | 23 April 2019 | Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Obeticholic Acid (OCA);Drug: Placebo | Intercept Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 217 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom | |
| 78 | NCT01430429 | December 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | Phase 2 | Italy;United Kingdom | ||
| 79 | EUCTR2011-004681-15-AT | 09/11/2011 | 9 December 2013 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: BEZAFIBRATE CAS Number: 41859-67-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Product Name: Ursodeoxycholsäure Pharmaceutical Form: Capsule CAS Number: 128-13-2 Other descriptive name: URSODEOXYCHOLIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | Medizinische Universität Graz | Not Recruiting | Female: yes Male: yes | Austria | |||||
| 80 | NCT01440309 | November 2011 | 19 February 2015 | 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 |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT01389973 | September 2011 | 19 October 2017 | 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 | Not recruiting | 18 Years | 99 Years | All | 20 | Phase 2 | United States;Canada | |
| 82 | NCT01603199 | September 2011 | 20 June 2016 | High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis | Impact of a High-protein High-fiber Diet on the Nutritional Status of Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Dietary Supplement: High protein high fiber diet | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Not recruiting | 18 Years | 70 Years | Both | 36 | N/A | Mexico | |
| 83 | EUCTR2011-001326-26-IT | 21/06/2011 | 29 October 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 Level: SOC 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 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: NI-0801 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | NOVIMMUNE BV | Not Recruiting | Female: yes Male: yes | 40 | Italy | ||||
| 84 | EUCTR2011-001326-26-GB | 27/05/2011 | 5 November 2012 | 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 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: NI-0801 Other descriptive name: fully human monoclonal antibody directed against CXCL10 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | NovImmune S.A. | Not Recruiting | Female: yes Male: yes | Italy;United Kingdom | |||||
| 85 | NCT01141296 | April 2011 | 19 February 2015 | 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 | Not recruiting | 21 Years | 75 Years | Both | 0 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT01249092 | November 2010 | 19 October 2017 | Pentoxifylline for Primary Biliary Cirrhosis | A Pilot Study of Pentoxifylline for the Treatment of Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Pentoxifylline | The Cleveland Clinic | Not recruiting | 18 Years | 76 Years | All | 20 | Phase 2 | United States | |
| 87 | JPRN-UMIN000003802 | 2010/04/01 | 2 April 2019 | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | phenylbutyrate(Child 250mg/kg/day)for 1-4months : phenylbutyrate(Child 350mg/kg/day)for 1-4months : phenylbutyrate(Child 500mg/kg/day)for 1-4months | Saiseikai Yokohama City Tobu Hospital | Laboratory of Molecular Pharmacokinetics, Graduate School of Pharmaceutical Sciences, The University of Tokyo (Tokyo) | Recruiting | Not applicable | Not applicable | Male and Female | 15 | Not selected | Japan | |
| 88 | NCT01857284 | September 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | 70 Years | Both | 216 | Phase 3 | China |
| 89 | NCT00943176 | June 2009 | 19 February 2015 | Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC) | Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis | Fatigue;Primary Biliary Cirrhosis | Drug: Modafinil | Mayo Clinic | American College of Gastroenterology | Not recruiting | 21 Years | 75 Years | Both | 40 | Phase 1 | United States |
| 90 | EUCTR2007-001424-12-GB | 21/04/2009 | 10 July 2015 | A Study of INT 747 Monotherapy in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 18.0 Level: PT Classification code 10004661 Term: Biliary cirrhosis primary System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: INT-747 Product Code: INT-747 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA or INT-747 or OCA Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: INT-747 Product Code: INT-747 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA or INT-747 or OCA Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: INT-747 Product Code: INT-747 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA or INT-747 or OCA Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: INT-747 Product Code: INT-747 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA or INT-747 or OCA Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA) Concentration unit: mg milligram(s) Concentration type: equal | Intercept Pharmaceuticals | Authorised | Female: yes Male: yes | 120 | France;Spain;Austria;Germany;United Kingdom | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT01510860 | November 2008 | 20 May 2019 | 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 | Not recruiting | 18 Years | N/A | All | 65 | Phase 4 | Germany | |
| 92 | EUCTR2007-001425-10-GB | 13/10/2008 | 19 March 2012 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA or INT-747 Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: INT-747 Product Code: INT-747 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA or INT-747 Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: INT-747 Product Code: INT-747 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Obeticholic acid CAS Number: 459789-99-2 Current Sponsor code: 6-ECDCA or INT-747 Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Intercept Pharmaceuticals | Not Recruiting | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | ||||
| 93 | EUCTR2007-004040-70-SE | 22/09/2008 | 19 February 2018 | Study to compare the combination of ursodeoxycholic acid and budesonide with the combination of ursodeoxycholic acid and placebo in the 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 Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333223 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Ursofalk Pharmaceutical Form: Capsule, hard INN or Proposed INN: URSODEOXYCHOLIC ACID CAS Number: 128132 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 94 | EUCTR2008-001524-31-DE | 26/08/2008 | 19 March 2012 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: URSODEOXYCHOLIC ACID CAS Number: 128132 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Ursofalk® 500 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: URSODEOXYCHOLIC ACID CAS Number: 128132 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | |||
| 95 | EUCTR2007-004040-70-DE | 15/05/2008 | 25 January 2016 | Study to compare the combination of ursodeoxycholic acid and budesonide with the combination of ursodeoxycholic acid and placebo in the 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 Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333223 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Ursofalk Pharmaceutical Form: Capsule, hard INN or Proposed INN: URSODEOXYCHOLIC ACID CAS Number: 128132 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | EUCTR2006-006742-34-GB | 20/12/2007 | 28 February 2019 | The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis. | The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis. | primary biliary cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis | Trade Name: Ezetrol Product Name: Ezetimibe Product Code: EZT Pharmaceutical Form: Tablet INN or Proposed INN: EZETIMIBE CAS Number: 163222-33-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10mg- Trade Name: pyridoxine 10mg BP Product Name: pyridoxine 10mg Product Code: A11HA02 Pharmaceutical Form: Tablet INN or Proposed INN: PYRIDOXINE CAS Number: 65236 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10MG- | Barts and The London NHS Trust | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United Kingdom | |||
| 97 | NCT00587119 | December 2007 | 19 February 2015 | Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis | Open-Label Pilot Study Evaluating Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis. | Primary Biliary Cirrhosis;Autoimmune Hepatitis | Drug: Budesonide | Mayo Clinic | Not recruiting | 21 Years | 75 Years | Both | 0 | N/A | United States | |
| 98 | NCT00570765 | November 2007 | 11 June 2018 | Study of INT-747 as Monotherapy in Patients With PBC | A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: Placebo;Drug: INT-747 | Intercept Pharmaceuticals | Not recruiting | 18 Years | 70 Years | All | 59 | Phase 2 | United States;Austria;Canada;France;Germany;Spain;United Kingdom | |
| 99 | NCT00550862 | October 2007 | 19 October 2017 | 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 | Not recruiting | 18 Years | 70 Years | All | 165 | Phase 2 | United States;Austria;Canada;France;Germany;Netherlands;Spain;United Kingdom | |
| 100 | NCT00575042 | August 2007 | 16 December 2017 | Use of Fenofibrate for Primary Biliary Cirrhosis | Pilot Study of Fenofibrate for Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Fenofibrate (Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P) | University of Florida | The PBCers Organization;Shionogi Inc. | Not recruiting | 21 Years | 75 Years | All | 20 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT00364819 | January 2007 | 16 December 2017 | Initial Study of Rituximab to Treat Primary Biliary Cirrhosis | Effects of Rituximab (Rituxan) on B Cell and AMA Response in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: rituximab | University of California, Davis | Genentech, Inc. | Not recruiting | 18 Years | 65 Years | Female | 6 | Phase 1/Phase 2 | United States |
| 102 | NCT00406237 | December 2006 | 19 February 2015 | Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis | Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: tigecycline | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | 8 | Phase 1 | United States;Puerto Rico | |
| 103 | EUCTR2006-003712-22-DE | 23/10/2006 | 28 January 2013 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ursodeoxycholic acid CAS Number: 128-13-2 Concentration unit: mg milligram(s) Concentration number: 500- | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 24 | Germany | ||||
| 104 | NCT00805805 | April 2006 | 16 December 2017 | Study Comparing Tetrathiomolybdate vs Standard Treatment in Primary Biliary Cirrhosis | Phase III Trial of Tetrathiomolybdate (TM) in Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Tetrathiomolybdate;Other: Placebo | George Brewer | FDA Office of Orphan Products Development | Not recruiting | 18 Years | N/A | All | 29 | Phase 3 | United States |
| 105 | NCT00393185 | January 2006 | 19 February 2015 | Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis | Non-myeloablative Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Primary Biliary Cirrhosis: A Phase I Study | Primary Biliary Cirrhosis | Biological: Non-myeloablative Hematopoietic Stem Cell Transplantation | Richard Burt, MD | Northwestern Memorial Hospital | Not recruiting | 18 Years | 55 Years | Both | 0 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT00844402 | January 2006 | 19 February 2015 | Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis | Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis;Hypercholesterolemia | Drug: Atorvastatin | Medical University of Graz | Not recruiting | 18 Years | 70 Years | Both | 40 | Phase 3 | Austria | |
| 107 | EUCTR2005-002160-28-AT | 23/09/2005 | 20 May 2013 | Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis | Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis | Reduction of cardiovascular risk may become key for the management of PBC. Therefore information on safety and efficacy (lipid-lowering effects) of statins in chronic cholestatic disorders is essential. Moreover, the study will answer the open question whether long-term treatment with statins may have potential beneficial effects on the course of PBC. | Trade Name: Sortis Product Name: Sortis 10 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Atorvastatin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology | Not Recruiting | Female: yes Male: yes | 80 | Austria | ||||
| 108 | NCT00125281 | July 25, 2005 | 16 December 2017 | SAMe to Treat Biliary Cirrhosis Symptoms | S-Adenosyl Methionine for Symptomatic Treatment of Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: S-adenosyl-methionine (SAMe) capsules | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 21 Years | N/A | All | 50 | Phase 2 | United States | |
| 109 | NCT00490620 | January 2004 | 19 February 2015 | Study of Combivir for Patients With Primary Biliary Cirrhosis | Randomized Controlled Pilot Study of Combivir for Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Combination antiviral therapy;Drug: Placebo | University of Alberta | GlaxoSmithKline;Axcan Pharma | Not recruiting | 18 Years | 75 Years | Both | 59 | Phase 2/Phase 3 | United States;Canada;United Kingdom |
| 110 | JPRN-C000000225 | 2003/12/01 | 2 April 2019 | 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 | Not Recruiting | 20years-old | 85years-old | Male and Female | 20 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | NCT00588302 | June 2003 | 19 February 2015 | Moexipril for Primary Biliary Cirrhosis | Open-Label Pilot Investigation of Moexipril for the Treatment of Primary Biliary Cirrhosis (PBC) | Primary Biliary Cirrhosis | Drug: Moexipril | Mayo Clinic | UCB Pharma | Not recruiting | 18 Years | 85 Years | Both | 20 | Phase 2 | United States |
| 112 | NCT00004784 | January 1994 | 19 February 2015 | 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 | Not recruiting | 20 Years | 69 Years | Both | 315 | Phase 3 | ||
| 113 | NCT00006168 | January 1994 | 19 February 2015 | Ursodiol-Methotrexate for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: Methotrexate | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 20 Years | 69 Years | Both | Phase 3 | United States | |||
| 114 | NCT00004748 | November 1989 | 19 February 2015 | 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 | Not recruiting | N/A | N/A | Both | 90 | Phase 3 |