93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 298 / 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05751967 (ClinicalTrials.gov) | February 22, 2023 | 13/12/2022 | Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis | A Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study: Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis and an Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cholangitis | Drug: Placebo Combined With Ursodeoxycholic Acid;Drug: Fenofibrate Combined With Ursodeoxycholic Acid | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 3 | China |
| 2 | NCT05749822 (ClinicalTrials.gov) | February 17, 2023 | 29/12/2022 | Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis | Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cholangitis | Drug: Fenofibrate 200mg;Drug: Placebo;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 75 Years | All | 104 | Phase 2/Phase 3 | China |
| 3 | EUCTR2022-001634-10-ES (EUCTR) | 23/01/2023 | 13/10/2022 | Study to Evaluate Safety, Tolerability and Efficacy in patients with Primary Biliary Cholangitis of Saroglitazar Magnesium-III (EPICS-III). | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects with Primary Biliary Cholangitis. - EPICS-III | Primary biliary Cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Saroglitazar Magnesium 1 mg INN or Proposed INN: SAROGLITAZAR MAGNESIUM Other descriptive name: SAROGLITAZAR MAGNESIUM Trade Name: Saroglitazar Magnesium 2 mg Product Name: Saroglitazar Magnesium 2 mg INN or Proposed INN: SAROGLITAZAR MAGNESIUM Other descriptive name: SAROGLITAZAR MAGNESIUM | Zydus Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 192 | Phase 2;Phase 3 | United States;Argentina;Spain;Turkey;Iceland;Colombia;United Kingdom;Italy | ||
| 4 | EUCTR2019-003158-10-GR (EUCTR) | 19/12/2022 | 25/10/2022 | Linerixibat Long-term Safety and Tolerability Study (LLSAT) | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC | Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC) MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: linerixibat (GSK2330672) 40 mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 305 | Phase 3 | United States;Czechia;Greece;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;China;Japan | ||
| 5 | NCT05624294 (ClinicalTrials.gov) | December 19, 2022 | 14/11/2022 | Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects | A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending Does Study of CS0159 to Evaluate the Safety, Tolerability, Pharmacokynetics, and Food Effect in Healthy Subjects | Primary Biliary Cholangitis | Drug: CS0159;Drug: Placebo | Cascade Pharmaceuticals, Inc | NULL | Recruiting | 18 Years | 55 Years | All | 36 | Phase 1 | China |
| 6 | NCT05525520 (ClinicalTrials.gov) | October 6, 2022 | 30/8/2022 | Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis | Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis | Pruritus | Drug: EP547;Drug: Placebo | Escient Pharmaceuticals, Inc | NULL | Recruiting | 18 Years | 80 Years | All | 58 | Phase 2 | United States |
| 7 | EUCTR2022-000422-16-HU (EUCTR) | 26/07/2022 | 24/05/2022 | A two-part study to investigate the effects in adults of two doses of a new drug called golexanolone in patients with primary biliary cholangitis with fatigue and cognitive dysfunction | A randomised, double-blind, placebo-controlled, two-part study to evaluate the pharmacokinetics, safety and tolerability, and preliminary efficacy of two dose levels of golexanolone in subjects with primary biliary cholangitis, fatigue, and cognitive dysfunction. | Primary biliary cholangitis (PBC) MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Golexanolone Product Code: GR3027 INN or Proposed INN: GOLEXANOLONE | Umecrine Cognition AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 101 | Phase 1;Phase 2 | Serbia;Hungary;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2021-000007-21-GR (EUCTR) | 28/06/2022 | 11/05/2022 | Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN) | A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC). - PH3a,linerixibat vsPBO,efficacy&safety,itch study for the treatment of cholestatic pruritus in PBC | Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC). MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK2330672/linerixibat 40 mg Product Code: GSK2330672/linerixibat 40 mg INN or Proposed INN: Linerixibat Other descriptive name: 3-({[(3R,5R)-3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,4-benzothiazepin-8-yl]methyl}amino)pentanedioic acid | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Czechia;Greece;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Bulgaria;Germany;China;Japan | ||
| 9 | EUCTR2021-000007-21-CZ (EUCTR) | 23/06/2022 | 12/04/2022 | Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN) | A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC). - PH3a,linerixibat vsPBO,efficacy&safety,itch study for the treatment of cholestatic pruritus in PBC | Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC). MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK2330672/linerixibat 40 mg Product Code: GSK2330672/linerixibat 40 mg INN or Proposed INN: Linerixibat Other descriptive name: 3-({[(3R,5R)-3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,4-benzothiazepin-8-yl]methyl}amino)pentanedioic acid | GlaxoSmithKline Research & Development Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Czechia;Greece;Israel;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;China;Japan | ||
| 10 | EUCTR2021-001431-56-FI (EUCTR) | 04/05/2022 | 10/03/2022 | Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC | primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norucholic acid (NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid Other descriptive name: norucholic acid | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;Finland;Poland;Belgium;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland | ||
| 11 | EUCTR2021-001389-39-DE (EUCTR) | 19/04/2022 | 01/10/2021 | A study to evaluate efficacy and safety of an investigational drug namedvolixibat in patients with itching caused by primary biliary cholangitis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluatethe Efficacy and Safety of Volixibat in the Treatment of CholestaticPruritus in Patients with Primary Biliary Cholangitis (VANTAGE) - VANTAGE | Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: volixibat INN or Proposed INN: volixibat potassium Other descriptive name: volixibat Product Name: volixibat INN or Proposed INN: volixibat potassium Other descriptive name: volixibat | Mirum Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | France;United States;Canada;Israel;Germany;United Kingdom;Italy | ||
| 12 | NCT05190523 (ClinicalTrials.gov) | April 6, 2022 | 13/12/2021 | Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: ASC42 5 mg;Drug: ASC42 10 mg;Drug: ASC42 15 mg;Drug: Placebo | Gannex Pharma Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 100 | Phase 2 | China |
| 13 | EUCTR2021-001810-13-SE (EUCTR) | 06/04/2022 | 30/11/2021 | A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM) | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Calliditas Therapeutics Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden | ||
| 14 | NCT05133336 (ClinicalTrials.gov) | April 1, 2022 | 1/11/2021 | Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis | A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: Saroglitazar Magnesium 1 mg;Drug: Saroglitazar Magnesium 2 mg;Drug: Placebo | Zydus Therapeutics Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 192 | Phase 2/Phase 3 | United States |
| 15 | JPRN-jRCTs051210210 | 30/03/2022 | 30/03/2022 | BIG STEP | Benefit of glucosyl Hesperidin in patients with primary biliary cholangitis: amulticenter, open-label, randomized control study | Primary Biliary Cholangitis Cholangitis | Participants will be randomly assigned to standard dose and high dose groups. In standard dose group, hesperidin tablet 500 mg (two tablets at a time once a day after meal) will be orally administered for 24 weeks. In high dose group, hesperidin tablet 1000mg (four tablets at a time once a day after meal) will be orally administered for 24 weeks. | Fujinaga Hisayuki | NULL | Recruiting | >= 20age old | Not applicable | Both | 110 | Phase 2 | Japan |
| 16 | NCT05293938 (ClinicalTrials.gov) | March 28, 2022 | 4/3/2022 | A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients | Study Evaluating the Effectiveness of Obeticholic Acid on Hepatic Real-World Outcomes in Patients With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: Obeticholic Acid 5 MG;Drug: Obeticholic Acid 10 MG;Drug: Standard of Care: UDCA | Intercept Pharmaceuticals | Global PBC Study Group;Target RWE;Syneos Health;UK PBC Study Group | Enrolling by invitation | 18 Years | N/A | All | 2350 | United States | |
| 17 | EUCTR2021-001431-56-DE (EUCTR) | 07/03/2022 | 03/11/2021 | Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acid | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC | primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norucholic acid (NCA) 500 mg Product Code: NCA 500mg INN or Proposed INN: Norucholic acid Other descriptive name: norucholic acid | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Finland;Spain;Lithuania;Austria;Switzerland;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands;Norway | ||
| 18 | EUCTR2020-004348-27-DK (EUCTR) | 04/03/2022 | 22/11/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA). MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand;United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary | ||
| 19 | NCT05014672 (ClinicalTrials.gov) | February 14, 2022 | 10/8/2021 | A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib With a 52-week Extension Phase in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness | Primary Biliary Cholangitis;Liver Stiffness | Drug: Setanaxib;Drug: Placebo | Calliditas Therapeutics Suisse SA | NULL | Recruiting | 18 Years | N/A | All | 318 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Hungary;Israel;Italy;New Zealand;Poland;Spain;Sweden;Switzerland;United Kingdom |
| 20 | EUCTR2021-001810-13-DE (EUCTR) | 10/02/2022 | 07/10/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 21 | EUCTR2019-003158-10-BE (EUCTR) | 31/01/2022 | 23/11/2021 | Linerixibat Long-term Safety and Tolerability Study (LLSAT) | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC | Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC) MedDRA version: 24.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: linerixibat (GSK2330672) 40 mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 305 | Phase 3 | United States;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;China;Japan | ||
| 22 | NCT05104853 (ClinicalTrials.gov) | January 25, 2022 | 22/10/2021 | Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis | A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18-75 With Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA | Primary Biliary Cholangitis | Drug: CNP-104;Drug: Placebo | COUR Pharmaceutical Development Company, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 40 | Phase 1/Phase 2 | United States |
| 23 | EUCTR2021-001810-13-IT (EUCTR) | 18/01/2022 | 05/11/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: [GKT137831] INN or Proposed INN: Setanaxib | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden | ||
| 24 | EUCTR2021-001810-13-ES (EUCTR) | 17/01/2022 | 19/10/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 25 | EUCTR2021-001810-13-AT (EUCTR) | 13/01/2022 | 11/10/2021 | A Trial of Setanaxib in Patients with Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM) | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Calliditas Therapeutics Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden | ||
| 26 | EUCTR2021-001810-13-PL (EUCTR) | 11/01/2022 | 28/10/2021 | A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM) | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Calliditas Therapeutics Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Germany;New Zealand;Sweden | ||
| 27 | EUCTR2021-001810-13-HU (EUCTR) | 11/12/2021 | 30/09/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden | ||
| 28 | EUCTR2021-001810-13-GR (EUCTR) | 07/12/2021 | 12/11/2021 | A Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with PBC and Elevated Liver Stiffness | TRANSFORM: A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness - TRANSFORM | Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: SETANAXIB Product Code: GKT137831 INN or Proposed INN: Setanaxib Other descriptive name: GYPP-06 (GKT137831 free base), C10071301-D | Genkyotex Suisse SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 318 | Phase 2;Phase 3 | United States;Czechia;Greece;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 29 | NCT05050136 (ClinicalTrials.gov) | September 22, 2021 | 9/9/2021 | A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis | Primary Biliary Cholangitis;PBC | Drug: Volixibat;Drug: Placebo | Mirum Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 260 | Phase 2 | United States;France;Germany;Israel;United Kingdom |
| 30 | NCT04950764 (ClinicalTrials.gov) | September 17, 2021 | 14/6/2021 | An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) | The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment | Primary Biliary Cholangitis;Compensated Cirrhosis;Hepatic Impairment | Drug: Seladelpar 10 mg;Drug: Seladelpar 10 mg or less | CymaBay Therapeutics, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 24 | Phase 1 | United States;Korea, Republic of;Spain;United Kingdom |
| 31 | NCT04950127 (ClinicalTrials.gov) | August 27, 2021 | 25/6/2021 | Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) | A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC) | Pruritus | Drug: Linerixibat;Drug: Placebo | GlaxoSmithKline | NULL | Recruiting | 18 Years | 80 Years | All | 230 | Phase 3 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Greece;Israel;Italy;Japan;Mexico;Poland;Russian Federation;United Kingdom |
| 32 | NCT04956328 (ClinicalTrials.gov) | July 22, 2021 | 1/7/2021 | Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC) | A Multi-center, Randomized, Double-blind Trail Evaluating the Efficacy and Safety of Combination of Obecholic Acid and UDCA Compared With UDCA Monotherapy in PBC Patients With an Inadequate Response to UDCA . | Primary Biliary Cirrhosis | Drug: Obeticholic Acid Tablets;Drug: UDCA;Drug: Placebo | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | NULL | Recruiting | 18 Years | 75 Years | All | 120 | Phase 3 | China |
| 33 | EUCTR2020-004348-27-RO (EUCTR) | 08/07/2021 | 19/04/2022 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Denmark;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 34 | EUCTR2020-004348-27-DE (EUCTR) | 07/07/2021 | 07/01/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Germany;New Zealand | ||
| 35 | EUCTR2020-005198-29-NL (EUCTR) | 28/06/2021 | 31/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3;Phase 4 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 36 | EUCTR2021-000007-21-IT (EUCTR) | 24/06/2021 | 17/08/2021 | Global Linerixibat Itch STudy of Efficacy and Safety iN PBC (GLISTEN) | A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC). - PH3a,linerixibat vsPBO,efficacy&safety,itch study for the treatment of cholestatic pruritus in PBC | Moderate to severe Cholestatic pruritus with primary biliary cholangitis (PBC). MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Linerixibat Product Code: [GSK2330672] INN or Proposed INN: Linerixibat Other descriptive name: 3-({[(3R,5R)-3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Poland;Germany;Netherlands;China;Japan | ||
| 37 | NCT04933292 (ClinicalTrials.gov) | June 16, 2021 | 1/5/2020 | A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome | A Randomised Clinical Trial Assessing the Efficacy and Safety of Mycophenolate Mofetil Versus Azathioprine for Induction of Remission in Treatment Primary Biliary Cholangitis-Autoimmune Hepatitis Overlap Syndrome | Autoimmune Hepatitis;Primary Biliary Cirrhosis | Drug: Methylprednisolone and Mycophenolate mofetil;Drug: Methylprednisolone and azathioprine | Xiaoli Fan | NULL | Recruiting | 18 Years | 70 Years | All | 78 | Phase 4 | China |
| 38 | NCT04376528 (ClinicalTrials.gov) | June 16, 2021 | 3/5/2020 | Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy | Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy | Hepatitis, Autoimmune;Primary Biliary Cholangitis;Immunosuppression | Drug: Cyclosporin A;Drug: Mycophenolate Mofetil | West China Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 89 | Phase 4 | China |
| 39 | EUCTR2020-004348-27-NL (EUCTR) | 08/06/2021 | 16/03/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand | ||
| 40 | EUCTR2020-005198-29-IT (EUCTR) | 04/06/2021 | 08/06/2021 | A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: SELADELPAR Product Code: [MBX-8025] INN or Proposed INN: seladelpar Product Name: seladelpar Product Code: [MBX-8025] INN or Proposed INN: seladelpar | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3;Phase 4 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 41 | ChiCTR2100046346 | 2021-06-01 | 2021-05-14 | A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis | A single-center, randomized, single-blind clinical study to evaluate the efficacy and safety of rifaximin in the treatment of primary biliary cholangitis | primary biliary cholangitis | Ursodeoxycholic acid group:Ursodeoxycholic acid;Rifaximin group :UDCA and rifaximin; | Xiangya Hospital of Central South University | NULL | Recruiting | 18 | 75 | Both | Ursodeoxycholic acid group:30;Rifaximin group :30; | N/A | China |
| 42 | NCT04893993 (ClinicalTrials.gov) | May 12, 2021 | 4/5/2021 | PBC Induced Fatigue Treated With Thiamine | PBC Induced Fatigue Treated With Thiamine (PIFT) - The Effect of Oral Thiamine Supplement in 4 Weeks to Patients With Primary Biliary Cholangitis (PBC) and Chronic Fatigue. A Randomised Placebo Controlled Crossover Study | Primary Biliary Cirrhosis | Drug: Thiamine;Drug: Placebo | Henning Grønbæk | Aarhus University Hospital;Hospitalsapoteket Region Midtjylland;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Region Hovedstadens Apotek | Recruiting | 18 Years | N/A | All | 36 | Phase 4 | Denmark |
| 43 | EUCTR2020-005198-29-DE (EUCTR) | 10/05/2021 | 05/02/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Greece;Spain;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 44 | EUCTR2020-005198-29-HU (EUCTR) | 06/05/2021 | 21/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3;Phase 4 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 45 | EUCTR2020-005198-29-PL (EUCTR) | 05/05/2021 | 17/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | Phase 3 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 46 | NCT04620733 (ClinicalTrials.gov) | April 21, 2021 | 4/11/2020 | RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA) | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: Seladelpar 10 mg;Drug: Placebo;Drug: Seladelpar 5 mg | CymaBay Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 193 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Chile;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;New Zealand;Poland;Romania;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Netherlands |
| 47 | EUCTR2019-004941-34-IT (EUCTR) | 13/04/2021 | 04/06/2021 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid - NA | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: [GFT505] | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany | ||
| 48 | NCT04618575 (ClinicalTrials.gov) | March 17, 2021 | 31/10/2020 | Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1 | A Randomized Controlled Open-label Clinical Trial of Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1 | Hepatitis;Primary Biliary Cholangitis;Autoimmune | Drug: Ursodeoxycholic acid combined with total glucosides of paeony;Drug: Ursodeoxycholic acid only | West China Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 137 | Phase 4 | China |
| 49 | EUCTR2020-004348-27-PL (EUCTR) | 16/03/2021 | 02/02/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Germany;New Zealand | ||
| 50 | EUCTR2020-004348-27-HU (EUCTR) | 04/03/2021 | 20/01/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 51 | EUCTR2020-004935-26-DK (EUCTR) | 25/02/2021 | 09/12/2020 | Vitamin B1 as treatment for chronic fatigue in patients with primary biliary cholangitis | PBC induced fatigue treated with thiamine- The effect of oral thiamine supplement in 4 weeks to patients with primary biliary cholangitis (PBC) and chronic fatigue.A randomised, double-blinded, placebo-controlled, crossover study - PIFT | Primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 20.1;Level: LLT;Classification code 10066564;Term: Chronic fatigue;System Organ Class: 100000004867;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Tiamin SAD INN or Proposed INN: THIAMINE Other descriptive name: Tiamin DAK | Aarhus University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | Denmark | ||
| 52 | EUCTR2020-001961-34-PL (EUCTR) | 24/02/2021 | 18/11/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC | Primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Belgium;Poland;Netherlands;Germany;United Kingdom | ||
| 53 | EUCTR2020-001961-34-SK (EUCTR) | 24/02/2021 | 02/10/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC | Primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 54 | EUCTR2020-004348-27-IT (EUCTR) | 16/02/2021 | 24/05/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) - RESPONSE | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA). MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: [MBX-8025] INN or Proposed INN: seladelpar Product Name: Seladelpar Product Code: [MBX-8025] INN or Proposed INN: seladelpar | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 55 | EUCTR2020-001961-34-DE (EUCTR) | 02/02/2021 | 14/09/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC | Primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 56 | EUCTR2019-003158-10-FR (EUCTR) | 26/01/2021 | 09/11/2020 | Linerixibat Long-term Safety and Tolerability Study | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC | Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC) MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: linerixibat (GSK2330672) 45mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | United States;France;Canada;Poland;United Kingdom;Japan | ||
| 57 | EUCTR2020-001961-34-IT (EUCTR) | 25/01/2021 | 24/05/2021 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC | Primary biliary cholangitis MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules Product Code: [RhuDex choline salt] INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules Product Code: [RhuDex choline salt] INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules Product Code: [RhuDex choline salt] INN or Proposed INN: RhuDex choline salt | DR. FALK PHARMA GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Czechia;Hungary;Slovakia;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 58 | ITMCTR2000004008 | 2021-01-01 | 2020-08-27 | Clinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MS | Clinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MS | primary biliary cholangitis | control group:placebo of Yuyinyanggan decoction +Ursodeoxycholic Acid Capsules ;experimental group:Yuyinyanggan decoction+Ursodeoxycholic Acid Capsules; | Shanghai Municipal Hospital of Traditional Chinese Medicine | NULL | Pending | Both | control group:96;experimental group:96; | China | |||
| 59 | ChiCTR2000037243 | 2021-01-01 | 2020-08-27 | Clinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MS | Clinical Study of therapeutic effect of Yuyinyanggan decoction on patients of primary biliary cholangitis with 25-OH-D by LC-MS/MS | primary biliary cholangitis | experimental group:Yuyinyanggan decoction+Ursodeoxycholic Acid Capsules;control group:placebo of Yuyinyanggan decoction +Ursodeoxycholic Acid Capsules ; | Shanghai Municipal Hospital of Traditional Chinese Medicine | NULL | Pending | Both | experimental group:96;control group:96; | China | |||
| 60 | EUCTR2020-001961-34-NL (EUCTR) | 15/12/2020 | 08/10/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC | Primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Belgium;Germany;Netherlands;United Kingdom | ||
| 61 | EUCTR2020-001961-34-BE (EUCTR) | 11/12/2020 | 23/10/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC | Primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Belgium;Netherlands;Germany;United Kingdom | ||
| 62 | EUCTR2018-002575-17-DE (EUCTR) | 09/12/2020 | 30/09/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 63 | ChiCTR2000040593 | 2020-12-01 | 2020-12-03 | Prevalence and prognostic risk of primary biliary cholangitis in Yunnan Province | Prevalence and prognostic risk of primary biliary cholangitis in Yunnan Province | primary biliary cholangitis | Gold Standard:PBC can be diagnosed by meeting 2 of the following 3 criteria :(1) serum biochemical indication of increased ALP;(2) When AMA is positive or AMA is negative, other PBC specific autoantibodies, such as SP100 and GP210 are positive;(3) Histological evidence suggested non-suppurative destructive cholangitis and inter-lobu;Index test:AMA in serum of suspected PBC cases was detected by traditional AMA-M2 test and BPO test, respectively.; | The Second Affiliated Hospital of Kunming Medical University | NULL | Pending | Male | Target condition:0;Difficult condition:0 | N/A | China | ||
| 64 | EUCTR2019-004941-34-FR (EUCTR) | 30/11/2020 | 09/10/2020 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: ELAFIBRANOR | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany | ||
| 65 | EUCTR2020-001961-34-HU (EUCTR) | 16/11/2020 | 17/09/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC | Primary biliary cholangitis MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules INN or Proposed INN: RhuDex choline salt | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary | ||
| 66 | NCT04617561 (ClinicalTrials.gov) | November 1, 2020 | 29/10/2020 | Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II | Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II:A Randomized Controlled Open-label Clinical Trial | Hepatitis, Autoimmune;Primary Biliary Cholangitis | Drug: Ursodeoxycholic acid;Drug: Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone) | West China Hospital | NULL | Recruiting | 18 Years | 70 Years | All | 90 | Phase 4 | China |
| 67 | EUCTR2019-004941-34-BE (EUCTR) | 09/10/2020 | 31/08/2020 | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: ELAFIBRANOR | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany | ||
| 68 | NCT04751188 (ClinicalTrials.gov) | October 2, 2020 | 5/2/2021 | A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis | Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response | Primary Biliary Cirrhosis | Drug: Bezafibrate 200 MG Oral Tablet;Drug: Placebo;Drug: Ursodeoxycholic Acid | Instituto Mexicano del Seguro Social | NULL | Active, not recruiting | 18 Years | 65 Years | All | 11 | Phase 3 | Mexico |
| 69 | ITMCTR2000004009 | 2020-10-01 | 2020-08-27 | A multicenter, randomized, double-blind, Tiaomian I study of PBC | A multicenter, randomized, double-blind, Tiaomian I study of PBC | Primary biliary cholangitis | control group:UDCA+Tiaomian I placebo;experimental group:UDCA+Tiaomian I; | Longhua Hospital ShangHai University of Traditional Chinese Medicine | NULL | Recruiting | Both | control group:45;experimental group:45; | China | |||
| 70 | ChiCTR2000037244 | 2020-10-01 | 2020-08-27 | A multicenter, randomized, double-blind, Tiaomian I study of PBC | A multicenter, randomized, double-blind, Tiaomian I study of PBC | Primary biliary cholangitis | control group:UDCA+Tiaomian I placebo;experimental group:UDCA+Tiaomian I; | Longhua Hospital ShangHai University of Traditional Chinese Medicine | NULL | Recruiting | Both | control group:45;experimental group:45; | China | |||
| 71 | NCT04526665 (ClinicalTrials.gov) | September 24, 2020 | 21/8/2020 | Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) | A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: Elafibranor 80mg;Drug: Placebo | Genfit | NULL | Active, not recruiting | 18 Years | 75 Years | All | 150 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;Chile;France;Germany;Italy;South Africa;Spain;Switzerland;Turkey;United Kingdom |
| 72 | EUCTR2018-004011-44-GB (EUCTR) | 10/08/2020 | 28/05/2020 | Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study | A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritus. - TURRIFIC Protocol Version 8 | Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin. MedDRA version: 20.1;Level: PT;Classification code 10049055;Term: Cholestasis of pregnancy;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 20.1;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Product Name: Rifampicin INN or Proposed INN: Rifampicin Product Name: Ursodeoxycholic acid INN or Proposed INN: Ursodeoxycholic acid | The University Of Adelaide | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 108 | Phase 3 | Finland;Australia;Netherlands;United Kingdom;Sweden | ||
| 73 | EUCTR2018-002575-17-AT (EUCTR) | 20/07/2020 | 07/04/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafilbrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Netherlands;Norway;Germany;Sweden;Korea, Republic of | ||
| 74 | NCT04167358 (ClinicalTrials.gov) | July 14, 2020 | 15/11/2019 | Linerixibat Long-term Safety, and Tolerability Study | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis | Cholestasis | Drug: Linerixibat | GlaxoSmithKline | NULL | Recruiting | 18 Years | 80 Years | All | 305 | Phase 3 | United States;Argentina;Brazil;Canada;China;France;Germany;Italy;Japan;Mexico;Poland;Russian Federation;Spain;United Kingdom |
| 75 | NCT03954327 (ClinicalTrials.gov) | June 29, 2020 | 7/5/2019 | Combination Antiretroviral Therapy (cART) for PBC | Randomized Controlled Trail (RCT) of Emtricitabine, Tenofovir Disoproxil and Raltegravir for Patients With Primary Biliary Cholangitis Unresponsive to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: Emtricitabine (FTC)/Tenofovir Disoproxil (TDF);Drug: Raltegravir;Drug: Placebo Oral Capsule [CEBOCAP] | University of Alberta | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Canada |
| 76 | EUCTR2019-003158-10-PL (EUCTR) | 22/06/2020 | 27/03/2020 | Linerixibat Long-term Safety and Tolerability Study (LLSAT) | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC | Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC) MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: linerixibat (GSK2330672) 45mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat Product Name: linerixibat (GSK2330672) 40 mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat Product Name: linerixibat (GSK2330672) 45 mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | France;United States;Canada;Poland;Italy;United Kingdom;Japan | ||
| 77 | EUCTR2018-002575-17-HR (EUCTR) | 05/06/2020 | 25/06/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Croatia;Australia;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 78 | EUCTR2019-003158-10-GB (EUCTR) | 04/06/2020 | 04/02/2020 | Linerixibat Long-term Safety and Tolerability Study | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC | Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC) MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: linerixibat (GSK2330672) 45mg Product Code: GSK2330672 INN or Proposed INN: Linerixibat | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Poland;Japan;United Kingdom | ||
| 79 | EUCTR2018-004011-44-FI (EUCTR) | 20/05/2020 | 26/09/2019 | Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study | A randomised trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study, comparing their effectiveness in the reduction of pruritis. - TURRIFIC | Intrahepatic Cholestasis of Pregnancy (ICP) is an serious liver condition in pregnancy. The main symptom of this is itching. Ursodeoxycholic acid is routinely used to treat cholestasis but is not effective in reducing itch in all people who take it. Rifampcin has been used to reduce itch in people with Primary Biliary Cholangitis. This study will randomly allocate women with severe early onset ICP to receive either Ursodeoxycholic Acid, or the Investigational drug Rifampicin.;Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] | Product Name: Rifampicin Product Name: Ursodeoxycholic acid | The University of Adelaide | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 108 | Phase 4 | Finland;Australia;Netherlands;United Kingdom;Sweden | ||
| 80 | EUCTR2019-003158-10-IT (EUCTR) | 14/05/2020 | 02/09/2021 | Linerixibat Long-term Safety and Tolerability Study | Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis - Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC | Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC) MedDRA version: 21.1;Level: PT;Classification code 10064190;Term: Cholestatic pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Linerixibat (GSK2330672) 45mg Product Code: [GSK2330672] INN or Proposed INN: Linerixibat | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | France;United States;Canada;Poland;United Kingdom;Japan;Italy | ||
| 81 | EUCTR2018-002575-17-PL (EUCTR) | 05/05/2020 | 09/01/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 82 | ChiCTR2000032053 | 2020-05-01 | 2020-04-19 | Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC) | Application value of ultrasonography combined with transient elastography for staging of hepatic fibrosis in patients with primary biliary cholangitis (PBC) | primary biliary cholangitis | Gold Standard:Any two of the following items met: 1. increased biochemical indicators of cholestasis such as alkaline phosphatase; 2. positive serum AMA or AMA-M2; 3. hepatic histopathology.;Index test:high-frequency and low-frequency ultrasound?transient elastography (TE); | You'an Hospital, Capital Medical University | NULL | Pending | 18 | 70 | Both | Target condition:100;Difficult condition:270 | N/A | China |
| 83 | NCT04650243 (ClinicalTrials.gov) | March 21, 2020 | 27/4/2020 | Clinical Research of UCDA Reducing Medication Regimen in Stable PBC | Clinical Research of Reducing Medication Regimen for Ursodeoxycholic Acid in Treatment of Stable Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: ursodeoxycholic acid | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 65 Years | All | 90 | Phase 4 | China |
| 84 | NCT04278820 (ClinicalTrials.gov) | March 20, 2020 | 18/1/2020 | A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC) | A Phase IIa, Randomized, Double-blind, Placebo-controlled Study of TQA3526 in the Treatment of Naive or Previously Treated PBC Patients | Primary Biliary Cirrhosis | Drug: TQA3526;Drug: Placebo to match TQA3526 | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | NULL | Not yet recruiting | 18 Years | 70 Years | All | 130 | Phase 2 | China |
| 85 | JPRN-UMIN000039350 | 2020/03/01 | 01/03/2020 | Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia | Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia - Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia | primary biliary cholangitis | pemafibrate for 12 months bezafibrate for 12 months | Shinshu University Faculty of Medicine, Department of Gastroenterology | NULL | Pending | 20years-old | 95years-old | Male and Female | 60 | Not selected | Japan |
| 86 | EUCTR2018-002575-17-CZ (EUCTR) | 27/02/2020 | 16/10/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 87 | EUCTR2018-002575-17-GB (EUCTR) | 14/02/2020 | 19/08/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 88 | EUCTR2018-002575-17-GR (EUCTR) | 14/02/2020 | 05/11/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 89 | NCT03521297 (ClinicalTrials.gov) | January 20, 2020 | 28/4/2018 | Probiotics in PBC Patients of Poor Response to UDCA | Safety and Efficacy of Probiotics in Primary Biliary Cholangitis (PBC) Patients With Poor Ursodeoxycholic Acid (UDCA) Response | Primary Biliary Cholangitis (PBC) | Drug: Probiotic;Dietary Supplement: Placebo | Sun Yat-sen University | NULL | Not yet recruiting | 18 Years | 70 Years | All | 60 | Phase 2 | China |
| 90 | EUCTR2018-002575-17-LT (EUCTR) | 17/01/2020 | 17/10/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | Czechia;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 91 | EUCTR2018-002575-17-SK (EUCTR) | 04/12/2019 | 20/09/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 92 | ChiCTR1900027043 | 2019-11-30 | 2019-10-29 | A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis | A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis | primary biliary cirrhosis | Experimental group:Sanxiao Powder and Erzhi Pill and UDCA;Control group:stimulant of Sanxiao Powder and Erzhi Pill and UDCA; | Longhua Hospital, Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Experimental group:136;Control group:136; | China | |
| 93 | ITMCTR1900025303 | 2019-11-30 | 2019-10-29 | A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis | A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis | primary biliary cirrhosis | Experimental group:Sanxiao Powder and Erzhi Pill and UDCA;Control group:stimulant of Sanxiao Powder and Erzhi Pill and UDCA; | Longhua Hospital, Shanghai University of Traditional Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | Experimental group:136;Control group:136; | China | |
| 94 | ITMCTR1900002705 | 2019-11-30 | 2019-10-23 | Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine | Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine | primary biliary cholangitis | Treatment group :nourishing kidney and activating blood granule and UDCA;Control group:Simulant nourishing kidney and activating blood granule and UDCA; | Longhua Hospital, Shanghai University of traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Treatment group :120;Control group:120; | China | |
| 95 | ChiCTR1900026813 | 2019-11-30 | 2019-10-23 | Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine | Study for the Standardized Treatment of Primary Biliary Cirrhosis With the Combination of Traditional Chinese and Western Medicine | primary biliary cholangitis | Treatment group :nourishing kidney and activating blood granule and UDCA;Control group:Simulant nourishing kidney and activating blood granule and UDCA; | Longhua Hospital, Shanghai University of traditional Chinese Medicine | NULL | Pending | 18 | 65 | Both | Treatment group :120;Control group:120; | China | |
| 96 | EUCTR2018-002575-17-ES (EUCTR) | 15/10/2019 | 26/07/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary BiliaryCholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | Estonia;Slovakia;Greece;Spain;Ireland;Israel;France;Denmark;Australia;Latvia;Netherlands;Korea, Republic of;Slovenia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Belgium;Poland;Croatia;Germany;Norway;Sweden | ||
| 97 | EUCTR2018-002575-17-FR (EUCTR) | 14/10/2019 | 09/07/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Estonia;Slovakia;Greece;Spain;Ireland;Israel;France;Denmark;Australia;Latvia;Netherlands;Korea, Republic of;Slovenia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Norway;Sweden | ||
| 98 | NCT04594694 (ClinicalTrials.gov) | October 2, 2019 | 14/7/2020 | Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Patients With PBC | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination With Bezafibrate in Subjects With Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis | Drug: Obeticholic acid;Drug: Bezafibrate 200 MG;Drug: OCA Placebo;Drug: Bezafibrate 200 mg Placebo;Drug: Bezafibrate 400 MG;Drug: Bezafibrate 400 mg Placebo | Intercept Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 75 | Phase 2 | Australia;Austria;Belgium;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Lithuania;Netherlands;Norway;Poland;Spain;Sweden;United Kingdom |
| 99 | NCT04076527 (ClinicalTrials.gov) | September 19, 2019 | 29/8/2019 | Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis | Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis | PBC;Primary Biliary Cholangitis | Drug: UDCA;Drug: Ocaliva | University of Leipzig | RWTH Aachen University;Zentrum für Klinische Studien Leipzig;Intercept Pharma Europe Limited (IPEL);Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);University Hospital Erlangen;Medical care center for Gastroenterology, Berlin;Institute for Interdisciplinary Medicine, Hamburg;Leberhilfe Projekt gUG, Cologne;Hannover Medical School | Recruiting | 18 Years | N/A | All | 1200 | Germany | |
| 100 | NCT04522869 (ClinicalTrials.gov) | August 10, 2019 | 4/9/2019 | Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia | Evaluation Safety and Efficacy of Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Liver Cirrhosis Due to Biliary Atresia: A Matched Control Prospective Study | Primary Biliary Cirrhosis | Biological: Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation | Vinmec Research Institute of Stem Cell and Gene Technology | Children's Hospital Number 2, Ho Chi Minh City, Vietnam | Recruiting | 5 Months | 2 Years | All | 34 | Phase 1/Phase 2 | Vietnam |
| 101 | ChiCTR1900024836 | 2019-07-30 | 2019-07-30 | Exploration of non-invasive diagnostic model of liver fibrosis based on artificial intelligence in primary biliary cholangitis Clinical research protocol | Exploration of non-invasive diagnostic model of liver fibrosis based on artificial intelligence in primary biliary cholangitis Clinical research protocol | Primary biliary cholangitis | Gold Standard:Liver biopsy pathology.;Index test:Non-invasive diagnostic model for liver fibrosis: including AST/PLT value index (APRI model), Forns model, S index, and based on this, a new non-invasive liver fibrosis diagnosis model is generated.; | Beijing You'an Hospital, Capital Medical University | NULL | Recruiting | 18 | 80 | Both | Target condition:180;Difficult condition:180 | China | |
| 102 | EUCTR2018-002575-17-HU (EUCTR) | 25/07/2019 | 04/06/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Greece;Finland;Spain;Ireland;Austria;Israel;United Kingdom;France;Hungary;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 103 | NCT03995212 (ClinicalTrials.gov) | June 25, 2019 | 19/6/2019 | 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. | NULL | Terminated | 18 Years | 80 Years | All | 14 | Phase 2 | United States |
| 104 | EUCTR2018-003365-34-GB (EUCTR) | 02/05/2019 | 11/02/2019 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA | Primary Biliary Cholangitis MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib Trade Name: Olumiant Product Name: Olumiant Product Code: LY3009104 INN or Proposed INN: BARICITINIB Other descriptive name: baricitinib | Eli Lilly and Company | NULL | Not Recruiting | Female: yes Male: yes | 52 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Italy;United Kingdom | ||
| 105 | EUCTR2018-001171-20-AT (EUCTR) | 29/04/2019 | 19/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 106 | EUCTR2018-001171-20-NL (EUCTR) | 18/04/2019 | 16/11/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | Serbia;United States;Greece;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Germany;Netherlands;New Zealand;Korea, Republic of | ||
| 107 | EUCTR2018-003365-34-IT (EUCTR) | 18/04/2019 | 03/08/2021 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA. | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA. - na | Primary Biliary Cholangitis MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] Trade Name: Olumiant Product Name: Olumiant Product Code: [LY3009104] Other descriptive name: baricitinib | ELI LILLY & COMPANY, LILLY CORPORATE CENTER | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | United States;United Kingdom;Italy | ||
| 108 | NCT03742973 (ClinicalTrials.gov) | March 28, 2019 | 14/11/2018 | A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA | A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Primary Biliary Cholangitis Who Have an Inadequate Response or Are Intolerant to UDCA | Primary Biliary Cholangitis | Drug: Baricitinib;Drug: Placebo | Eli Lilly and Company | NULL | Terminated | 18 Years | N/A | All | 2 | Phase 2 | United States;Puerto Rico;Italy;United Kingdom |
| 109 | EUCTR2018-001171-20-BE (EUCTR) | 06/03/2019 | 29/01/2019 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 110 | EUCTR2018-001171-20-FR (EUCTR) | 23/01/2019 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 111 | EUCTR2017-003528-62-BE (EUCTR) | 11/01/2019 | 24/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Canada;Austria;Netherlands;Belgium;United States;United Kingdom;Australia;France;Germany;Spain | ||
| 112 | EUCTR2017-001762-13-LT (EUCTR) | 31/12/2018 | 25/10/2018 | A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3;Phase 4 | United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Brazil;Belgium;Australia;Germany | ||
| 113 | EUCTR2018-001171-20-PL (EUCTR) | 27/12/2018 | 06/11/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 114 | EUCTR2018-001171-20-ES (EUCTR) | 21/12/2018 | 18/01/2019 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 115 | ChiCTR1800020160 | 2018-12-20 | 2018-12-18 | Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis | Clinical research for fenofibrate in the treatment of refractory primary biliary cirrhosis | Primary Biliary Cirrhosis | 1:Fenofibrate+UDCA;2:UDCA; | Peking Union Medical College Hosipital | NULL | Recruiting | 18 | 65 | Both | 1:20;2:20; | China | |
| 116 | EUCTR2018-001171-20-DE (EUCTR) | 20/12/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 3 | United States;Serbia;Greece;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of | ||
| 117 | EUCTR2017-003528-62-DE (EUCTR) | 05/12/2018 | 16/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 118 | EUCTR2017-001762-13-EE (EUCTR) | 04/12/2018 | 15/10/2018 | A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3;Phase 4 | United States;Estonia;Spain;Lithuania;Switzerland;Italy;United Kingdom;Hungary;Argentina;Brazil;Belgium;Australia;Germany | ||
| 119 | EUCTR2017-003528-62-NL (EUCTR) | 29/11/2018 | 09/07/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | United States;France;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;United Kingdom | ||
| 120 | EUCTR2017-001762-13-DE (EUCTR) | 27/11/2018 | 27/06/2018 | A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3;Phase 4 | United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Brazil;Belgium;Australia;Germany | ||
| 121 | EUCTR2018-001171-20-HU (EUCTR) | 26/11/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 122 | EUCTR2018-001171-20-GR (EUCTR) | 23/11/2018 | 18/10/2018 | A clinical trial to assess the safety and efficacy of seladelpar in patients with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA). | Primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis) is a serious and potentially life threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids (BA).;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Korea, Republic of | ||
| 123 | EUCTR2018-001171-20-IT (EUCTR) | 08/11/2018 | 17/06/2021 | A clinical trial to assess the safety and efficacy of seladelpar in patientswith primary biliary cholangitis (PBC) and an inadequate response to orintolerance to ursodeoxycholic acid (UDCA). | A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate thesafety and efficacy of seladelpar in subjects with primary biliary cholangitis(PBC) and an inadequate response to or intolerance to ursodeoxycholicacid (UDCA). - NA | Primary biliary cholangitis (PBC, formerly known as primary biliarycirrhosis) is a serious and potentially life threatening autoimmunedisease of the liver characterized by impaired bile flow (cholestasis) andaccumulation of toxic bile acids (BA). MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: seladelpar Product Code: [MXB-8025] INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: [MBX-8025] INN or Proposed INN: seladelpar | CymaBay Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of;Serbia;United States;Greece;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil | ||
| 124 | EUCTR2017-001762-13-IT (EUCTR) | 25/10/2018 | 22/01/2021 | 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 withPrimary Biliary Cholangitis and Moderate to Severe Hepatic Impairment - NA | Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment MedDRA version: 20.0;Level: LLT;Classification code 10032965;Term: Other symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: [INT-747, OCA] INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: [INT-747, OCA] INN or Proposed INN: Obeticholic Acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 | INTERCEPT PHARMACEUTICALS INC. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Brazil;Belgium;Australia;Germany | ||
| 125 | EUCTR2017-001762-13-BE (EUCTR) | 24/10/2018 | 14/08/2018 | A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3;Phase 4 | United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Belgium;Brazil;Australia;Germany | ||
| 126 | EUCTR2017-003528-62-AT (EUCTR) | 19/10/2018 | 25/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | Canada;Austria;Netherlands;Belgium;United States;United Kingdom;Australia;France;Germany;Spain | ||
| 127 | NCT03602560 (ClinicalTrials.gov) | October 1, 2018 | 18/7/2018 | ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) | A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: seladelpar 5-10 mg;Drug: seladelpar 10 mg;Drug: Placebo | CymaBay Therapeutics, Inc. | NULL | Completed | 18 Years | 75 Years | All | 265 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Spain;United Kingdom |
| 128 | EUCTR2017-001762-13-HU (EUCTR) | 28/08/2018 | 29/08/2018 | A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Brazil;Belgium;Australia;Germany | ||
| 129 | EUCTR2017-003528-62-ES (EUCTR) | 28/08/2018 | 24/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 130 | EUCTR2017-001762-13-ES (EUCTR) | 01/08/2018 | 20/06/2018 | A clinical trial where neither the doctor, patient or sponsor know whether aplacebo 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 INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), oCA, INT-747 | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | United States;Estonia;Spain;Lithuania;Switzerland;United Kingdom;Italy;Hungary;Argentina;Belgium;Brazil;Australia;Germany | ||
| 131 | EUCTR2017-003528-62-GB (EUCTR) | 27/07/2018 | 22/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 132 | NCT03633227 (ClinicalTrials.gov) | June 22, 2018 | 8/4/2018 | Study of OCA Evaluating Pharmacokinetics and Safety in Patients With PBC and Hepatic Impairment | 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 | Liver Cirrhosis, Biliary | Drug: Obeticholic Acid (OCA);Drug: Placebo | Intercept Pharmaceuticals | NULL | Terminated | 18 Years | 85 Years | All | 22 | Phase 4 | United States;Argentina;Australia;Belgium;Brazil;Canada;Estonia;Germany;Hungary;Italy;Lithuania;Spain |
| 133 | EUCTR2016-003817-80-FR (EUCTR) | 09/05/2018 | 08/03/2018 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid | Primary biliary cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor | Genfit SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;France;Spain;Germany;United Kingdom | ||
| 134 | NCT03476993 (ClinicalTrials.gov) | April 27, 2018 | 20/3/2018 | Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis | Open-label Non-comparative Study to Evaluate the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis | Liver Cirrhosis, Biliary | Biological: BCD-085 | Biocad | NULL | Terminated | 18 Years | 60 Years | All | 9 | Phase 2 | Russian Federation |
| 135 | JPRN-UMIN000031384 | 2018/03/16 | 20/02/2018 | Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) | Efficacy and safety of Denosumab treatment for osteoporosis in patients with primary biliary cholangitis; a randomized controlled trial with zoledronic acid (DELTA Study) - 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 | Complete: follow-up complete | 20years-old | 89years-old | Male and Female | 80 | Not selected | Japan |
| 136 | EUCTR2016-004599-23-IT (EUCTR) | 26/02/2018 | 07/01/2021 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess theEfficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase - GSN00300 | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 | GENKYOTEX SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 137 | EUCTR2017-003910-16-GB (EUCTR) | 08/02/2018 | 15/11/2017 | A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis | An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025, DSIC INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025, DSIC INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025, Formulation 2 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025, Formulation 2 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3;Phase 4 | Argentina;Russian Federation;Romania;Hungary;United States;United Kingdom;Spain;Greece;New Zealand;Canada;Netherlands;Belgium;Korea, Republic of;Poland;Italy;Mexico;Israel;Australia;Chile;France;Serbia;Germany | ||
| 138 | NCT03345589 (ClinicalTrials.gov) | January 30, 2018 | 6/11/2017 | 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 | NULL | Unknown status | 18 Years | 70 Years | All | 40 | Phase 4 | China |
| 139 | EUCTR2017-003910-16-DE (EUCTR) | 29/01/2018 | 04/12/2017 | A study to evaluate the safety and tolerability of seladelpar in subjects with primary biliary cholangitis | An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2;Phase 3 | United States;Canada;Germany;United Kingdom | ||
| 140 | EUCTR2014-005012-42-PT (EUCTR) | 08/01/2018 | 29/08/2017 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 141 | NCT03665519 (ClinicalTrials.gov) | January 3, 2018 | 6/9/2018 | Clinical Trial on the Effect of the Sublimated Mare Milk Supplement on Primary Biliary Cholangitis | Clinical Trial on the Effect of Sublimated Mare Milk Supplement in Patients With Biliary Cholangitis | Primary Biliary Cirrhosis | Dietary Supplement: Sublimated mare milk;Drug: Ursodeoxycholic Acid | National Scientific Medical Center, Kazakhstan | Eurasia Invest Ltd.;Ministry of Education and Science, Republic of Kazakhstan | Completed | 18 Years | 75 Years | All | 40 | N/A | Kazakhstan |
| 142 | NCT03394924 (ClinicalTrials.gov) | December 27, 2017 | 23/12/2017 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: EDP-305 Dose 1;Drug: EDP-305 Dose 2;Drug: Placebo | Enanta Pharmaceuticals | Pharmaceutical Research Associates;Triangle Biostatistics | Completed | 18 Years | 75 Years | All | 68 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom |
| 143 | NCT03155932 (ClinicalTrials.gov) | December 15, 2017 | 11/5/2017 | 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 | NULL | Terminated | 18 Years | 80 Years | All | 2 | Phase 2 | United States;Australia;New Zealand |
| 144 | NCT03301506 (ClinicalTrials.gov) | December 12, 2017 | 26/9/2017 | Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) | ASSURE: 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 5 mg Capsule;Drug: Seladelpar 10 mg Capsule | CymaBay Therapeutics, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 500 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Chile;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Romania;Russian Federation;Spain;United Kingdom |
| 145 | EUCTR2014-001438-27-ES (EUCTR) | 29/11/2017 | 10/10/2017 | 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 INN or Proposed INN: BEZAFIBRATE | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 84 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Netherlands | ||
| 146 | EUCTR2016-002416-41-PL (EUCTR) | 14/11/2017 | 05/09/2017 | 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: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 20.0;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 INN or Proposed INN: GSK2330672 Other descriptive name: GSK2330672 Product Name: GSK2330672 Product Code: GSK2330672 INN or Proposed INN: GSK2330672 Other descriptive name: GSK2330672 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;France;Canada;Spain;Poland;Australia;Netherlands;United Kingdom;Japan | ||
| 147 | EUCTR2016-004599-23-GR (EUCTR) | 27/10/2017 | 06/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Greece;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 148 | JPRN-JapicCTI-173728 | 05/10/2017 | 05/10/2017 | Pharmacokinetic study of K-877 in patients with Primary biliary cholangitis | Pharmacokinetic study of K-877 in patients with Primary biliary cholangitis | Primary biliary cholangitis | Intervention name : Pemafibrate INN of the intervention : Pemafibrate Dosage And administration of the intervention : Oral dose Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kowa Co., Ltd. | NULL | complete | 20 | BOTH | 8 | Phase 1 | Japan | |
| 149 | EUCTR2016-004599-23-DE (EUCTR) | 19/09/2017 | 10/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 150 | NCT03112681 (ClinicalTrials.gov) | August 18, 2017 | 10/4/2017 | 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 | NULL | Active, not recruiting | 18 Years | 75 Years | All | 37 | Phase 2 | United States |
| 151 | EUCTR2016-004599-23-BE (EUCTR) | 10/08/2017 | 10/04/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Spain;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 152 | EUCTR2016-002416-41-IT (EUCTR) | 01/08/2017 | 15/12/2020 | 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). - Dose response study of GSK2330672 for the treatment of pruritus in patients with primary biliary cho | Primary biliary cholangitis (PBC) MedDRA version: 20.0;Level: PT;Classification code 10037087;Term: Pruritus;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: GSK2330672 Product Code: GSK2330672 INN or Proposed INN: GSK2330672 Product Name: GSK2330672 Product Code: GSK2330672 INN or Proposed INN: GSK2330672 | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;France;Canada;Poland;Spain;Australia;Netherlands;United Kingdom;Japan;Italy | ||
| 153 | EUCTR2016-004599-23-ES (EUCTR) | 26/07/2017 | 04/07/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000023866;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 2 | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 154 | EUCTR2016-002965-67-NL (EUCTR) | 07/07/2017 | 29/03/2017 | 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) | AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 155 | EUCTR2016-004599-23-GB (EUCTR) | 30/06/2017 | 17/05/2017 | A study assessing the efficacy and safety of GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients with Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and with Persistently Elevated Alkaline Phosphatase | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: GKT137831 INN or Proposed INN: GKT137831 Other descriptive name: GKT137831 | Genkyotex SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 102 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Greece;Canada;Belgium;Spain;Israel;Germany;Italy;United Kingdom | ||
| 156 | EUCTR2016-003817-80-GB (EUCTR) | 31/05/2017 | 08/03/2017 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | Primary biliary cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor | Genfit SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Spain;Germany;United Kingdom | ||
| 157 | NCT03092765 (ClinicalTrials.gov) | May 29, 2017 | 24/3/2017 | Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid | A Clinical Phase 2 Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid | Primary Biliary Cholangitis | Drug: E6011;Drug: Placebo | EA Pharma Co., Ltd. | NULL | Terminated | 20 Years | 74 Years | All | 29 | Phase 2 | Japan |
| 158 | EUCTR2016-003817-80-ES (EUCTR) | 22/05/2017 | 08/03/2017 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | Primary biliary cholangitis MedDRA version: 19.1;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor | Genfit SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | France;United States;Spain;Germany;United Kingdom | ||
| 159 | NCT03188146 (ClinicalTrials.gov) | May 1, 2017 | 8/6/2017 | Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid | Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) | Drug: Ursodeoxycholic Acid | Humanity and Health Research Centre | Beijing 302 Hospital | Recruiting | 18 Years | 85 Years | All | 500 | China | |
| 160 | NCT03124108 (ClinicalTrials.gov) | April 5, 2017 | 28/3/2017 | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) | Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo | Genfit | NULL | Completed | 18 Years | 75 Years | All | 45 | Phase 2 | United States;France;Germany;Spain;United Kingdom |
| 161 | EUCTR2016-002416-41-GB (EUCTR) | 24/03/2017 | 19/01/2017 | 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: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 20.0;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 INN or Proposed INN: GSK2330672 Other descriptive name: GSK2330672 Product Name: GSK2330672 Product Code: GSK2330672 INN or Proposed INN: GSK2330672 Other descriptive name: GSK2330672 | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Poland;Spain;Australia;Netherlands;Japan;United Kingdom | ||
| 162 | EUCTR2014-005012-42-NL (EUCTR) | 23/02/2017 | 11/11/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 163 | EUCTR2016-002996-91-DE (EUCTR) | 21/02/2017 | 17/11/2016 | A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 164 | EUCTR2016-002416-41-ES (EUCTR) | 17/02/2017 | 09/12/2016 | 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;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 INN or Proposed INN: GSK2330672 Other descriptive name: GSK2330672 Product Name: GSK2330672 Product Code: GSK2330672 INN or Proposed INN: GSK2330672 Other descriptive name: GSK2330672 | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;France;Canada;Poland;Spain;Australia;Netherlands;Italy;United Kingdom;Japan | ||
| 165 | EUCTR2015-001590-41-PL (EUCTR) | 09/02/2017 | 05/01/2017 | 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 - Multi-part, double blind study to assess safety, tolerability and efficacy of LJN452 in PBC patients | 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 Code: LJN452 INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452 INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452 INN or Proposed INN: tropifexor Other descriptive name: LJN452 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 152 | Phase 2 | United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom | ||
| 166 | NCT03082937 (ClinicalTrials.gov) | January 31, 2017 | 27/2/2017 | 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 | NULL | Completed | 30 Years | 65 Years | Male | 6 | Phase 1 | United Kingdom |
| 167 | EUCTR2016-002443-42-AT (EUCTR) | 31/01/2017 | 21/12/2016 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects 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 MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-9674 30 mg INN or Proposed INN: not available Product Code: GS-9674 100 mg INN or Proposed INN: not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Austria;United Kingdom | ||
| 168 | EUCTR2016-002996-91-GB (EUCTR) | 12/01/2017 | 21/11/2016 | A study evaluating the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) | Primary Biliary Cholangitis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: Seladelpar Other descriptive name: MBX-8025 | CymaBay Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 169 | NCT02966834 (ClinicalTrials.gov) | January 11, 2017 | 15/11/2016 | 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 | NULL | Completed | 18 Years | 80 Years | All | 147 | Phase 2 | United States;Australia;Canada;France;Germany;Italy;Japan;Poland;Spain;United Kingdom |
| 170 | EUCTR2016-002443-42-GB (EUCTR) | 09/01/2017 | 16/11/2016 | An investigational study to assess the safety and efficacy of a new investigational drug in subjects 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 MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Code: GS-9674 INN or Proposed INN: Not available Product Code: GS-9674 INN or Proposed INN: Not available | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Austria;United Kingdom | ||
| 171 | NCT02943447 (ClinicalTrials.gov) | December 1, 2016 | 13/6/2016 | Study to Evaluate the 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 | NULL | Terminated | 18 Years | 70 Years | All | 71 | Phase 2 | United States;Austria;Canada;United Kingdom |
| 172 | NCT03489889 (ClinicalTrials.gov) | December 2016 | 12/1/2018 | Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine | Development of Ursodeoxycholic Acid 300 mg at Hospital Das Clinicas of the University of São Paulo School of Medicine | Ursodeoxycholic Acid;Primary Biliary Cirrhosis | Drug: Ursodeoxycholic Acid 300mg tablet;Drug: Ursodeoxycholic Acid 300mg capsule | University of Sao Paulo General Hospital | NULL | Completed | 18 Years | N/A | All | 30 | N/A | Brazil |
| 173 | NCT02936596 (ClinicalTrials.gov) | December 2016 | 15/10/2016 | Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome | Biochemical Response of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents | Hepatitis, Autoimmune;Cholangitis;Liver Cirrhosis, Biliary;Cholestasis | Drug: Ursodeoxycholic acid combination of immunosuppressive agents;Drug: Ursodeoxycholic Acid | Xiaoli Fan | NULL | Recruiting | 18 Years | 75 Years | All | 53 | N/A | China |
| 174 | NCT02937012 (ClinicalTrials.gov) | October 2016 | 13/10/2016 | Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders | Efficacy and Security of Bezafibrate in Patients With Primary Biliary Cirrhosis Without Biochemical Response to Ursodeoxycholic Acid: A Randomized, Double-blind, Placebo-controlled Trial | Primary Biliary Cirrhosis | Drug: Bezafibrate;Drug: Ursodeoxycholic Acid;Drug: Placebo (for Bezafibrate) | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | NULL | Unknown status | 18 Years | 65 Years | All | 34 | Phase 3 | Mexico |
| 175 | EUCTR2014-005012-42-BG (EUCTR) | 23/08/2016 | 06/07/2016 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT) | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT) | 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] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 176 | NCT03253276 (ClinicalTrials.gov) | May 19, 2016 | 28/5/2017 | 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 | NULL | Completed | 18 Years | 85 Years | All | 8 | Early Phase 1 | Denmark |
| 177 | NCT02823353 (ClinicalTrials.gov) | April 8, 2016 | 28/1/2016 | Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study | Primary Biliary Cirrhosis | Drug: Fenofibrate;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Completed | 18 Years | 70 Years | All | 117 | Phase 3 | China |
| 178 | EUCTR2015-002698-39-PL (EUCTR) | 03/03/2016 | 08/01/2016 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). | Primary Biliary Cirrhosis MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 179 | EUCTR2014-005012-42-DE (EUCTR) | 08/02/2016 | 04/01/2016 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary CholangitisThe COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | Portugal;United States;Serbia;Hong Kong;Estonia;Spain;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 180 | NCT02701166 (ClinicalTrials.gov) | February 2016 | 2/3/2016 | 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 |
| 181 | EUCTR2015-001590-41-DE (EUCTR) | 11/01/2016 | 13/01/2016 | 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 - Multi-part, double blind study to assess safety, tolerability and efficacy of LJN452 in PBC patients | 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 Code: LJN452, 0,01 mg INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452, 0,03 mg INN or Proposed INN: tropifexor Other descriptive name: LJN452 Product Code: LJN452, 0,1 mg INN or Proposed INN: tropifexor Other descriptive name: LJN452 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 152 | Phase 2 | United States;Canada;Poland;Russian Federation;Germany;China;United Kingdom | ||
| 182 | EUCTR2014-005012-42-HU (EUCTR) | 05/01/2016 | 23/09/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland | ||
| 183 | NCT02916290 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Fuzhenghuayu;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | |
| 184 | NCT02965911 (ClinicalTrials.gov) | January 2016 | 15/11/2016 | Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA | A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA | Primary Biliary Cirrhosis | Drug: Fenofibrate;Drug: UDCA | Beijing 302 Hospital | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 1/Phase 2 | China |
| 185 | NCT02823366 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: Fenofibrate;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 70 Years | All | 104 | Phase 3 | China | |
| 186 | NCT02916641 (ClinicalTrials.gov) | January 2016 | 28/1/2016 | Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: Fuzhenghuayu;Drug: UDCA | Xijing Hospital of Digestive Diseases | NULL | Recruiting | 18 Years | 70 Years | Both | 200 | Phase 3 | China | |
| 187 | EUCTR2014-005012-42-LT (EUCTR) | 31/12/2015 | 28/09/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 428 | Phase 4 | Portugal;Serbia;United States;Hong Kong;Estonia;Spain;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden | ||
| 188 | EUCTR2015-002698-39-DE (EUCTR) | 18/12/2015 | 30/09/2015 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). | Primary Biliary Cirrhosis MedDRA version: 19.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 INN or Proposed INN: NA Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 INN or Proposed INN: NA Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 189 | EUCTR2014-005012-42-ES (EUCTR) | 18/12/2015 | 30/10/2015 | A Phase 3b clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cirrhosis. | A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis | 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: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6?-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;United States;Serbia;Estonia;Spain;Chile;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 190 | EUCTR2014-005012-42-BE (EUCTR) | 17/12/2015 | 29/09/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 428 | Phase 4 | Hong Kong;United States;Portugal;Austria;Netherlands;Sweden;Brazil;Korea, Republic of;Poland;Bulgaria;Chile;France;Lithuania;Serbia;Argentina;Hungary;United Kingdom;Switzerland;Spain;New Zealand;Canada;Turkey;Belgium;Finland;Denmark;Italy;Mexico;Israel;Australia;Germany;Estonia | ||
| 191 | EUCTR2014-005012-42-FI (EUCTR) | 14/12/2015 | 02/10/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against aplacebo, in conjunction with standard treatment, on selected clinicalmeasurements in patients with the liver disease, Primary BiliaryCholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT). | A Phase 4, Double Blind, Randomized, Placebo Controlled, MulticenterStudy Evaluating the Effect of Obeticholic Acid on Clinical Outcomes inSubjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in LiverTreatment (COBALT). | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | Portugal;United States;Serbia;Hong Kong;Estonia;Spain;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 192 | EUCTR2014-005012-42-FR (EUCTR) | 03/12/2015 | 03/12/2015 | A Phase 3b clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cirrhosis | A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis | 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: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 350 | Phase 3 | Portugal;United States;Serbia;Estonia;Spain;Chile;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 193 | EUCTR2014-005012-42-AT (EUCTR) | 26/11/2015 | 28/09/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 194 | EUCTR2014-005012-42-DK (EUCTR) | 24/11/2015 | 29/09/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT) | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | Portugal;United States;Serbia;Hong Kong;Estonia;Spain;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 195 | EUCTR2014-005012-42-GB (EUCTR) | 19/11/2015 | 09/10/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis. The COBALT Study Clinical Outcomes with OBeticholic Acid in Liver Treatment (COBALT). | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 428 | Phase 4 | United States;Portugal;Serbia;Estonia;Hong Kong;Spain;Chile;Israel;Switzerland;Italy;France;Denmark;Australia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden | ||
| 196 | EUCTR2015-002698-39-GB (EUCTR) | 11/11/2015 | 17/09/2015 | A Study Evaluating the Effects of Two Doses of MBX-8025 Compared to a Placebo in Patients with Primary Biliary Cirrhosis (PBC) who have not responded to previous treatment with ursodeoxycholic acid (UDCA). | A 12-week, double-blind, randomized, placebo-controlled, Phase 2 study to evaluate the effects of two doses of MBX-8025 in subjects with Primary Biliary Cirrhosis (PBC) and an inadequate response to ursodeoxycholic acid (UDCA). | Primary Biliary Cirrhosis MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MBX-8025 Product Code: MBX-8025 Other descriptive name: MBX-8025 Product Name: MBX 8025 Product Code: MBX 8025 Other descriptive name: MBX-8025 | CymaBay Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | United States;Canada;Poland;Germany;United Kingdom | ||
| 197 | EUCTR2014-005012-42-EE (EUCTR) | 09/11/2015 | 12/10/2015 | A Phase 4 clinical trial to measure the effect of Obeticholic acid against a placebo, in conjunction with standard treatment, on selected clinical measurements in patients with the liver disease, Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with Obeticholic Acid in Liver Treatment (COBALT) | A Phase 4, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cholangitis.The COBALT Study Clinical Outcomes with Obeticholic Acid in Liver Treatment (COBALT) | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, INT-747 Trade Name: Ocaliva Product Name: Obeticholic acid Product Code: OCA, INT-747 INN or Proposed INN: Obeticholic Acid Other descriptive name: 6a-ethylchenodeoxycholic acid (6-ECDCA), OCA, Int-747 | Intercept Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 428 | Phase 4 | Portugal;United States;Serbia;Estonia;Spain;Israel;Chile;Switzerland;Italy;France;Australia;Denmark;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;New Zealand;Sweden;Finland;Hong Kong;Hungary | ||
| 198 | NCT02557360 (ClinicalTrials.gov) | November 2015 | 21/9/2015 | 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 | Completed | N/A | N/A | All | 24 | Phase 4 | Poland |
| 199 | NCT02609048 (ClinicalTrials.gov) | November 2015 | 13/11/2015 | Study to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) | A 12-week, Double-blind, Randomized, Placebo-controlled, Phase 2 Study, to Evaluate the Effects of Two Doses of MBX-8025 in Subjects With Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cirrhosis (PBC) | Drug: Placebo Comparator;Drug: Experimental: Seladelpar / MBX-8025 50 mg;Drug: Experimental: Seladelpar / MBX-8025 200 mg | CymaBay Therapeutics, Inc. | NULL | Terminated | 18 Years | 75 Years | All | 41 | Phase 2 | United States;Canada;Germany;Poland;United Kingdom |
| 200 | NCT02516605 (ClinicalTrials.gov) | September 9, 2015 | 4/8/2015 | 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 | NULL | Completed | 18 Years | N/A | All | 61 | Phase 2 | United States;Canada;Germany;Poland;Russian Federation;United Kingdom |
| 201 | EUCTR2014-001438-27-NL (EUCTR) | 19/08/2015 | 20/07/2015 | 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 | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Netherlands | |||
| 202 | NCT02321306 (ClinicalTrials.gov) | May 2015 | 12/12/2014 | 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. | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States;United Kingdom |
| 203 | NCT02193360 (ClinicalTrials.gov) | May 2015 | 11/7/2014 | 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 | NULL | Recruiting | 18 Years | 75 Years | Both | 24 | Phase 1/Phase 2 | Netherlands;United Kingdom |
| 204 | EUCTR2014-001638-27-GB (EUCTR) | 16/02/2015 | 11/12/2014 | A dose finding study of FFP104 for patients with Primary Biliary Cirrhosis (PBC) | 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) - Pilot Study of FFP104 Dose Escalation in PBC Subjects | Primary Biliary Cirrhosis (PBC) MedDRA version: 19.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FFP104 | Fast Forward Pharmaceuticals, B.V. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands;United Kingdom | ||
| 205 | NCT02360852 (ClinicalTrials.gov) | January 2015 | 14/1/2015 | 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 | Terminated | 18 Years | 80 Years | All | 9 | Phase 2 | Sweden |
| 206 | EUCTR2014-004070-42-SE (EUCTR) | 09/12/2014 | 15/10/2014 | Study to Demonstrate the Efficacy and Safety of A4250 in Patients withPrimary Biliary Cirrhosis and Cholestatic Pruritus | An Exploratory, Phase IIa Cross-Over Study to Demonstrate the Efficacyand Safety of A4250 in Patients with Primary Biliary Cirrhosis andCholestatic Pruritus | Primary biliary cirrhosis complicated by cholestatic pruritus.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: A4250 | Sahlgrenska Academy | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| 207 | NCT02308111 (ClinicalTrials.gov) | December 2014 | 10/11/2014 | 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 | NULL | Active, not recruiting | 18 Years | N/A | All | 428 | Phase 4 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Denmark;Estonia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Bulgaria;Former Serbia and Montenegro;New Zealand;Portugal;Serbia |
| 208 | EUCTR2014-001638-27-NL (EUCTR) | 15/10/2014 | 21/07/2014 | A dose finding study of FFP104 for patients with Primary Biliary Cirrhosis (PBC) | 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) - Pilot Study of FFP104 Dose Escalation in PBC Subjects | Primary Biliary Cirrhosis (PBC) MedDRA version: 18.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: FFP104 | Fast Forward Pharmaceuticals, B.V. | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Netherlands;United Kingdom | ||
| 209 | NCT02078882 (ClinicalTrials.gov) | September 2014 | 3/3/2014 | Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis | Abatacept For The Treatment Of Primary Biliary Cirrhosis With An Incomplete Biochemical Response To Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Biological: abatacept | Christopher Bowlus, MD | Bristol-Myers Squibb | Completed | 18 Years | N/A | All | 16 | Phase 4 | United States |
| 210 | NCT02135536 (ClinicalTrials.gov) | May 2014 | 8/5/2014 | 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 | Completed | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Australia;New Zealand |
| 211 | NCT01899703 (ClinicalTrials.gov) | March 10, 2014 | 3/7/2013 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus | A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of GSK2330672 Administration in Patients With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus | Cholestasis, Intrahepatic | Drug: GSK2330672;Drug: Placebo;Drug: Ursodeoxycholic acid | GlaxoSmithKline | NULL | Completed | 18 Years | 75 Years | All | 22 | Phase 2 | United Kingdom |
| 212 | JPRN-UMIN000012782 | 2014/02/01 | 01/02/2014 | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. - 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 | NULL | Pending | Not applicable | Not applicable | Male and Female | 2 | Not selected | Japan |
| 213 | NCT02026401 (ClinicalTrials.gov) | February 2014 | 30/12/2013 | Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis | A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Biological: NGM282;Biological: Placebo | NGM Biopharmaceuticals, Inc | NGM Biopharmaceuticals Australia Pty Ltd | Completed | 18 Years | 75 Years | All | 45 | Phase 2 | United States;Australia |
| 214 | JPRN-UMIN000012489 | 2013/12/04 | 04/12/2013 | Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis | Efficacy of anti-RANKL human antibody (Denosumab) on prevention of osteoporosis with primary biliary cirrhosis - Efficacy of Denosumab for osteoporosis patients with PBC | 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 | NULL | Complete: follow-up continuing | 20years-old | Not applicable | Male and Female | 20 | Not applicable | Japan |
| 215 | JPRN-UMIN000012193 | 2013/11/01 | 01/11/2013 | Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis | Efficacy of the anti-RANKL human antibody (Denosumab) versus Bisphosphonate for the treatment of osteoporosis in patients with primary biliary cirrhosis - Denosumab versus Bisphosphonate for osteoporosis in patients with PBC | 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 | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not applicable | Japan |
| 216 | NCT01865812 (ClinicalTrials.gov) | November 2013 | 23/5/2013 | 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 | NULL | Completed | 18 Years | N/A | All | 26 | Phase 2 | United States |
| 217 | NCT01904058 (ClinicalTrials.gov) | August 2013 | 17/7/2013 | Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis | A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis | PBC;Primary Biliary Cirrhosis | Drug: LUM001;Drug: Placebo;Drug: Ursodeoxycholic Acid | Mirum Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 80 Years | All | 66 | Phase 2 | United States;Canada;United Kingdom |
| 218 | EUCTR2013-000482-36-GB (EUCTR) | 08/07/2013 | 13/05/2013 | Phase 2 study to investigate use of LUM001 as a treatment for Primary Biliary Cirrhosis (PBC). This is a chronic and slowly progressive cholestatic liver disease of autoimmune aetiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. | A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS. - CLARITY STUDY | Primary biliary cirrhosis (PBC) is a chronic and slowly progressive cholestatic liver disease of autoimmune etiology characterized by injury of the intrahepatic bile ducts that may eventually lead to liver failure. Affected individuals are usually in their fifthto seventh decades of life at time of diagnosis, and 90% are women. MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: LUM001 INN or Proposed INN: LUM001 | Lumena Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United States;United Kingdom | ||
| 219 | NCT02963077 (ClinicalTrials.gov) | July 2013 | 1/11/2016 | 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 | NULL | Completed | 18 Years | 60 Years | Both | 94 | Phase 1 | NULL |
| 220 | NCT01879735 (ClinicalTrials.gov) | June 2013 | 11/6/2013 | 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 | NULL | Completed | 18 Years | N/A | All | 22 | Phase 1 | Denmark |
| 221 | EUCTR2007-004040-70-PL (EUCTR) | 30/04/2013 | 20/03/2013 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden | ||
| 222 | JPRN-UMIN000015789 | 2012/11/30 | 29/11/2015 | Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation | Tolerance induction by a regulartory T cell-based cell therapy in living donor liver transplantation - Operational tolerance by a Treg therapy in LDLT | 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 | NULL | Recruiting | 18years-old | 65years-old | Male and Female | 10 | Phase 1,2 | Japan |
| 223 | NCT01654731 (ClinicalTrials.gov) | October 15, 2012 | 30/7/2012 | Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Multicenter, Randomized, Double-blind Placebo Controlled Trial of Bezafibrate for the Treatment of Primary Biliary Cirrhosis in Patients With Incomplete Response to Ursodesoxycholic Acid Therapy. | PBC | Drug: Bezafibrate;Drug: placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | France |
| 224 | NCT02376335 (ClinicalTrials.gov) | October 2012 | 24/2/2015 | B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis | B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis | Fatigue;Primary Biliary Cirrhosis | Biological: Rituximab;Other: Placebo | Newcastle-upon-Tyne Hospitals NHS Trust | National Institute for Health Research, United Kingdom;Department of Health, United Kingdom;Newcastle University | Completed | 18 Years | N/A | All | 71 | Phase 2 | United Kingdom |
| 225 | EUCTR2012-000145-12-GB (EUCTR) | 15/08/2012 | 04/07/2012 | 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® INN or Proposed INN: Rituximab Other descriptive name: N/A | The Newcastle upon Tyne Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 58 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 226 | EUCTR2011-004728-36-NL (EUCTR) | 01/06/2012 | 15/02/2012 | 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: 18.0;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) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 227 | NCT01614405 (ClinicalTrials.gov) | June 2012 | 25/4/2011 | 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) | Completed | 18 Years | N/A | Both | 13 | N/A | Canada |
| 228 | EUCTR2011-004728-36-PL (EUCTR) | 30/05/2012 | 20/04/2012 | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | A Phase 3, Double Blind, Placebo Controlled Trial and Long Term SafetyExtension 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) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Spain;Austria;Switzerland;United Kingdom;Italy;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 229 | EUCTR2011-004728-36-SE (EUCTR) | 16/04/2012 | 16/02/2012 | 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 SafetyExtension 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) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 230 | EUCTR2011-004728-36-BE (EUCTR) | 30/03/2012 | 13/02/2012 | 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 SafetyExtension 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) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 231 | EUCTR2011-004728-36-DE (EUCTR) | 22/03/2012 | 16/02/2012 | 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 SafetyExtension 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) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 232 | EUCTR2011-004728-36-AT (EUCTR) | 13/03/2012 | 20/02/2012 | 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) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Belgium;Australia;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 233 | EUCTR2011-004728-36-IT (EUCTR) | 13/03/2012 | 05/03/2012 | 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 - A study of OCA in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 14.1;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) INN or Proposed INN: Acido Obeticolico Other descriptive name: Obeticholic Acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Acido Obeticolico Other descriptive name: Obeticholic Acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Acido Obeticolico Other descriptive name: Obeticholic Acid | INTERCEPT PHARMACEUTICALS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 234 | EUCTR2011-004728-36-GB (EUCTR) | 09/03/2012 | 23/02/2012 | 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 SafetyExtension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Trade Name: Ocaliva Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | United States;Canada;Poland;Spain;Belgium;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 235 | EUCTR2011-004728-36-ES (EUCTR) | 22/02/2012 | 22/02/2012 | 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: 14.1;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) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid Product Name: OCA (INT-747) Product Code: OCA (INT-747) INN or Proposed INN: Obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Austria;Switzerland;United Kingdom;Italy;France;Canada;Poland;Belgium;Germany;Netherlands;Sweden | ||
| 236 | NCT01473524 (ClinicalTrials.gov) | January 2012 | 14/11/2011 | 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 | NULL | Completed | 18 Years | N/A | All | 217 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Poland;Spain;Sweden;United Kingdom |
| 237 | NCT01430429 (ClinicalTrials.gov) | December 2011 | 5/9/2011 | Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody | An Open Label Single Arm Study to Investigate the Safety and Efficacy of Multiple Administrations of NI-0801, a Fully Human Anti-CXCL10 Monoclonal Antibody in PBC Patients With an Incomplete Response to Ursodeoxycholic Acid | Primary Biliary Cirrhosis | Drug: NI-0801 | NovImmune SA | NULL | Terminated | 18 Years | N/A | Both | Phase 2 | Italy;United Kingdom | |
| 238 | EUCTR2011-004681-15-AT (EUCTR) | 09/11/2011 | 19/10/2011 | Effects of the activation of PPARs in the orphan hepatic disease primary biliary cirrhosis | Effects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis - Effects of the activation of PPARs in patients with PBC | Up to 67% of PBC patients have an incomplete biochemical response to UDCA and remain at increased risk for progression to cirrhosis and liver-related death. In this study we will prospectively examine the therapeutic effects of bezafibrate (a pan-agonist activating PPARalpha/delta/gamma) in patients with early-stage PBC with a specific focus on improvement of liver functions, inflammation, lipid profile, oxidative status and endothelial function.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezafibrat Genericon retard 400 mg Product Name: Bezafibrat Product Code: 1-20190 INN or Proposed INN: BEZAFIBRATE Product Name: Ursodeoxycholsäure Other descriptive name: URSODEOXYCHOLIC ACID | Medizinische Universität Graz | NULL | Not Recruiting | Female: yes Male: yes | Austria | ||||
| 239 | NCT01440309 (ClinicalTrials.gov) | November 2011 | 20/9/2011 | Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis | Phase I Clinical Trial, Randomized, Controlled, to Evaluate the Efficacy and Safety of Therapy With Allogenic Mesenchymal Stem Cells From Bone Marrow for Patients With Refractory Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Biological: Biological: mesenchymal stem cell;Drug: ursodeoxycholic acid | Robert Chunhua Zhao, MD, PhD | Peking Union Medical College Hospital | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 1 | China |
| 240 | EUCTR2011-000554-31-SE (EUCTR) | 26/10/2011 | 16/08/2011 | A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic Acid | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI | Primary Biliary Cirrhosis MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | France;United States;Canada;Germany;Italy;United Kingdom;Sweden | ||
| 241 | EUCTR2011-000554-31-GB (EUCTR) | 21/09/2011 | 12/07/2011 | A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic Acid | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects with Primary Biliary Cirrhosis Who had an Inadequate Response to Ursodeoxycholic Acid (UDCA) - PURIFI | Primary Biliary Cirrhosis MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: Ustekinumab Other descriptive name: N/A | Janssen-Cilag International N.V. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 2 | France;United States;Canada;Germany;Italy;United Kingdom;Sweden | ||
| 242 | NCT01389973 (ClinicalTrials.gov) | September 2011 | 7/7/2011 | A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy and Safety of Ustekinumab in Subjects With Primary Biliary Cirrhosis Who Had an Inadequate Response to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cirrhosis | Drug: ustekinumab 90 mg;Drug: ustekinumab 45 mg;Drug: ustekinumab 180 mg;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 99 Years | All | 20 | Phase 2 | United States;Canada |
| 243 | NCT01603199 (ClinicalTrials.gov) | September 2011 | 17/5/2012 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 36 | N/A | Mexico |
| 244 | EUCTR2011-001326-26-IT (EUCTR) | 21/06/2011 | 19/01/2012 | Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. | Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human anti-CXCL10 monoclonal antibody. An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO | Proven PBC, as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: - History of increased ALP levels for at least 6 months - Positive serum AMA titer (>1:40) - Liver biopsy consistent with PBC Patient should be on incomplete response to UDCA MedDRA version: 14.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: NI-0801 Product Code: NI-0801 | NOVIMMUNE BV | NULL | Not Recruiting | Female: yes Male: yes | 40 | Italy | |||
| 245 | EUCTR2011-001326-26-GB (EUCTR) | 27/05/2011 | 24/03/2011 | Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody. | PIANO. Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI-0801, a fully human anti-CXCL10 monoclonal antibody.An open label single arm study to investigate the safety and efficacy of multiple administrations of NI-0801, a fully human anti-CXCL10 monoclonal antibody in primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO | Primary biliary cirrhosis MedDRA version: 14.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: NI-0801 Other descriptive name: fully human monoclonal antibody directed against CXCL10 | NovImmune S.A. | NULL | Not Recruiting | Female: yes Male: yes | Italy;United Kingdom | ||||
| 246 | NCT01141296 (ClinicalTrials.gov) | April 2011 | 8/6/2010 | Fenofibrate in Combination With Ursodeoxycholic Acid (UDCA) in Primary Biliary Cirrhosis | Randomized Controlled Study of Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: fenofibrate;Drug: placebo | University of Miami | Mayo Clinic | Withdrawn | 21 Years | 75 Years | Both | 0 | Phase 2 | United States |
| 247 | NCT01249092 (ClinicalTrials.gov) | November 2010 | 24/11/2010 | 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 | NULL | Completed | 18 Years | 76 Years | All | 20 | Phase 2 | United States |
| 248 | JPRN-UMIN000003802 | 2010/04/01 | 22/06/2010 | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. | Efficacy and safety of 4-phenylbutyrate in refractory cholestatic disease including progressive familial intrahepatic cholestasis, primary biliary cirrhosis, primary sclerosing cholangitis and Alagille syndrome. - 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 |
| 249 | NCT01857284 (ClinicalTrials.gov) | September 2009 | 16/5/2013 | Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis | A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Tauroursodeoxycholic Acid Capsules;Drug: Ursodeoxycholic Acid Capsules | Beijing Friendship Hospital | Beijing Trendful Kangjian Medical Information Consulting Limited Company | Completed | 18 Years | 70 Years | Both | 216 | Phase 3 | China |
| 250 | EUCTR2007-004040-70-GB (EUCTR) | 01/06/2009 | 19/08/2008 | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 251 | NCT00943176 (ClinicalTrials.gov) | June 2009 | 17/7/2009 | 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 | Completed | 21 Years | 75 Years | Both | 40 | Phase 1 | United States |
| 252 | EUCTR2007-004040-70-IT (EUCTR) | 20/05/2009 | 22/05/2009 | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Patients with PBC and with risk of a progression of this disease. MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budesonide INN or Proposed INN: Budesonide Trade Name: acido ursodessicolico INN or Proposed INN: Ursodeoxycholic acid | DR. FALK PHARMA GMBH | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | Sweden;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Poland;Denmark;Germany;Netherlands | ||
| 253 | EUCTR2007-001424-12-DE (EUCTR) | 22/04/2009 | 23/10/2008 | A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Spain;Austria;Germany;United Kingdom | ||
| 254 | EUCTR2007-001424-12-GB (EUCTR) | 21/04/2009 | 03/09/2007 | 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 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o , obeticholic acid (OCA) Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA) Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o, obeticholic acid (OCA) | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Austria;Germany;United Kingdom | ||
| 255 | EUCTR2007-004040-70-AT (EUCTR) | 19/03/2009 | 23/06/2008 | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 256 | EUCTR2007-001424-12-AT (EUCTR) | 13/03/2009 | 09/09/2008 | A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Spain;Austria;Germany;United Kingdom | ||
| 257 | EUCTR2007-001425-10-AT (EUCTR) | 13/03/2009 | 27/08/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 258 | EUCTR2007-001425-10-NL (EUCTR) | 11/02/2009 | 03/09/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 259 | NCT00746486 (ClinicalTrials.gov) | February 2009 | 3/9/2008 | Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC) | Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study Comparing the Combination of Ursodeoxycholic Acid Capsules Plus Budesonide Capsules to Ursodeoxycholic Acid Capsules Plus Placebo in the Treatment of Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: budesonide;Drug: budesonide placebo | Dr. Falk Pharma GmbH | NULL | Terminated | 18 Years | N/A | All | 62 | Phase 3 | France;Germany |
| 260 | EUCTR2007-004040-70-DK (EUCTR) | 29/01/2009 | 19/11/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 261 | EUCTR2007-001425-10-DE (EUCTR) | 27/01/2009 | 24/10/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | United Kingdom;Germany;Netherlands;France;Spain;Austria | |||
| 262 | EUCTR2007-004040-70-LT (EUCTR) | 22/12/2008 | 16/09/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 263 | EUCTR2008-001524-31-NL (EUCTR) | 26/11/2008 | 17/07/2008 | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | ||
| 264 | EUCTR2007-004040-70-FI (EUCTR) | 10/11/2008 | 25/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 265 | NCT01510860 (ClinicalTrials.gov) | November 2008 | 12/1/2012 | Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis | Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: UDCA (Ursodeoxycholic acid) | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | N/A | All | 65 | Phase 4 | Germany |
| 266 | EUCTR2007-004040-70-HU (EUCTR) | 18/10/2008 | 04/08/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 14.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 267 | EUCTR2007-001425-10-GB (EUCTR) | 13/10/2008 | 27/06/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: Obeticholic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid, 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-o | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Germany;United Kingdom;Netherlands;France;Spain;Austria | |||
| 268 | EUCTR2007-004040-70-ES (EUCTR) | 01/10/2008 | 01/08/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis) - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis) - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Pacientes con cirrosis biliar primaria con riesgo de progresíon de la enfermedadPatients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 269 | EUCTR2007-001425-10-FR (EUCTR) | 26/09/2008 | 06/08/2008 | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 270 | EUCTR2007-001425-10-ES (EUCTR) | 24/09/2008 | 23/07/2008 | Estudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | Estudio del INT-747 (6-ECDCA) en combinación con el ácido ursodesoxicólico (URSO®, UDCA) en pacientes con cirrosis biliar primariaA Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis | cirrosis biliar primaria MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Spain;Austria;Germany;Netherlands;United Kingdom | ||
| 271 | EUCTR2007-004040-70-SE (EUCTR) | 22/09/2008 | 02/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 272 | EUCTR2007-004040-70-FR (EUCTR) | 09/09/2008 | 09/06/2008 | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden | ||
| 273 | EUCTR2008-001524-31-DE (EUCTR) | 26/08/2008 | 11/07/2008 | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | ||
| 274 | EUCTR2007-004040-70-NL (EUCTR) | 11/08/2008 | 23/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden | ||
| 275 | EUCTR2007-001424-12-FR (EUCTR) | 29/07/2008 | 16/05/2008 | A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | A Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | Primary biliary cirrhosis MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Spain;Austria;Germany;United Kingdom | ||
| 276 | EUCTR2007-001424-12-ES (EUCTR) | 15/07/2008 | 22/05/2008 | Estudio de la monoterapia INT-747 (6-ECDCA) en pacientes concirrosis biliar primariaA Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | Estudio de la monoterapia INT-747 (6-ECDCA) en pacientes concirrosis biliar primariaA Study of INT-747 (6-ECDCA) Monotherapy in Patientswith Primary Biliary Cirrhosis | cirrosis biliar primaria MedDRA version: 9.1;Level: PT;Classification code 10004661;Term: Biliary cirrhosis primary | Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid, 6-ethylchenodeoxycholic acid Product Name: INT-747 Product Code: INT-747 INN or Proposed INN: 3a,7a-dihydroxy-6a-ethyl-5ßcholan-24-oic acid Other descriptive name: 6a-ethylchenodeoxycholic acid , 6-ethylchenodeoxycholic acid | Intercept Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Spain;Austria;Germany;United Kingdom | ||
| 277 | EUCTR2007-004040-70-DE (EUCTR) | 15/05/2008 | 14/03/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 278 | EUCTR2006-006742-34-GB (EUCTR) | 20/12/2007 | 03/06/2007 | 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 INN or Proposed INN: EZETIMIBE Trade Name: pyridoxine 10mg BP Product Name: pyridoxine 10mg Product Code: A11HA02 INN or Proposed INN: PYRIDOXINE | Barts and The London NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 279 | NCT00587119 (ClinicalTrials.gov) | December 2007 | 21/12/2007 | 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 | NULL | Withdrawn | 21 Years | 75 Years | Both | 0 | N/A | United States |
| 280 | NCT00570765 (ClinicalTrials.gov) | November 2007 | 7/12/2007 | 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 | NULL | Completed | 18 Years | 70 Years | All | 59 | Phase 2 | United States;Austria;Canada;France;Germany;Spain;United Kingdom |
| 281 | NCT00550862 (ClinicalTrials.gov) | October 2007 | 27/10/2007 | Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC) | A Study of INT 747 (6a-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: INT-747;Drug: Ursodeoxycholic Acid (URSO);Drug: Placebo | Intercept Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 165 | Phase 2 | United States;Austria;Canada;France;Germany;Netherlands;Spain;United Kingdom |
| 282 | NCT00575042 (ClinicalTrials.gov) | August 2007 | 13/12/2007 | Use of Fenofibrate for Primary Biliary Cirrhosis | Pilot Study of Fenofibrate for Primary Biliary Cirrhosis | Primary Biliary Cirrhosis | Drug: Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) | University of Florida | The PBCers Organization;Shionogi Inc. | Completed | 21 Years | 75 Years | All | 20 | Phase 2 | United States |
| 283 | NCT00364819 (ClinicalTrials.gov) | January 2007 | 15/8/2006 | 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. | Completed | 18 Years | 65 Years | Female | 6 | Phase 1/Phase 2 | United States |
| 284 | NCT00406237 (ClinicalTrials.gov) | December 2006 | 29/11/2006 | 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 | NULL | Completed | 18 Years | N/A | Both | 8 | Phase 1 | United States;Puerto Rico |
| 285 | EUCTR2006-003712-22-DE (EUCTR) | 23/10/2006 | 18/09/2006 | Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers | Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers | Primary Biliary Cirrhosis Stage I-III MedDRA version: 12.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® 500 mg Filmtabletten Product Name: Ursofalk® 500 mg Filmtabletten INN or Proposed INN: Ursodeoxycholic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany | |||
| 286 | NCT00805805 (ClinicalTrials.gov) | April 2006 | 8/12/2008 | 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 | Completed | 18 Years | N/A | All | 29 | Phase 3 | United States |
| 287 | NCT00393185 (ClinicalTrials.gov) | January 2006 | 24/10/2006 | 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 | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 1 | United States |
| 288 | NCT00844402 (ClinicalTrials.gov) | January 2006 | 13/2/2009 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 40 | Phase 3 | Austria |
| 289 | EUCTR2005-002160-28-AT (EUCTR) | 23/09/2005 | 19/08/2005 | 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 INN or Proposed INN: Atorvastatin | Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology | NULL | Not Recruiting | Female: yes Male: yes | 80 | Austria | |||
| 290 | NCT00125281 (ClinicalTrials.gov) | July 25, 2005 | 29/7/2005 | 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) | NULL | Terminated | 21 Years | N/A | All | 50 | Phase 2 | United States |
| 291 | NCT00490620 (ClinicalTrials.gov) | January 2004 | 21/6/2007 | 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 | Completed | 18 Years | 75 Years | Both | 59 | Phase 2/Phase 3 | United States;Canada;United Kingdom |
| 292 | JPRN-C000000225 | 2003/12/01 | 13/09/2008 | Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis | Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis - GLSG,2004,PBC | Primary biliary cirrhosis | Intervention:UDCA+Bezafibrate Bezafibrate: 400mg/day for 12 months Dose of pretreatment UDCA is not changed after entry. control:UDCA only Dose of pretreatment UDCA is not changed after entry. | Gunma Liver Study Group | NULL | Complete: follow-up complete | 20years-old | 85years-old | Male and Female | 20 | Not applicable | Japan |
| 293 | NCT00588302 (ClinicalTrials.gov) | June 2003 | 22/12/2007 | 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 | Completed | 18 Years | 85 Years | Both | 20 | Phase 2 | United States |
| 294 | NCT01161953 (ClinicalTrials.gov) | March 2002 | 12/7/2010 | Genetic Epidemiology of Primary Biliary Cirrhosis (PBC) | Understanding the Genetic Predisposition to the Development of Primary Biliary Cirrhosis (PBC). | Primary Biliary Cirrhosis | Genetic: Genetic Analysis | Mayo Clinic | NULL | Active, not recruiting | 18 Years | 90 Years | All | 1500 | United States | |
| 295 | NCT00004784 (ClinicalTrials.gov) | January 1994 | 24/2/2000 | Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: methotrexate;Drug: ursodiol | National Center for Research Resources (NCRR) | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);University of Texas | Completed | 20 Years | 69 Years | Both | 315 | Phase 3 | NULL | |
| 296 | NCT00006168 (ClinicalTrials.gov) | January 1994 | 8/8/2000 | Ursodiol-Methotrexate for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: Methotrexate | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 20 Years | 69 Years | Both | Phase 3 | United States | ||
| 297 | NCT00004748 (ClinicalTrials.gov) | November 1989 | 24/2/2000 | Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis | Liver Cirrhosis, Biliary | Drug: colchicine;Drug: methotrexate;Drug: ursodiol | National Center for Research Resources (NCRR) | Tufts Medical Center | Completed | N/A | N/A | Both | 90 | Phase 3 | NULL |
| 298 | EUCTR2020-005198-29-FR (EUCTR) | 29/03/2021 | A study to evaluate the safety and tolerability of seladelpar in subjectswith primary biliary cholangitis | ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE | Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR | CymaBay Therapeutics, Inc. | NULL | NA | Female: yes Male: yes | 500 | Phase 3;Phase 4 | United States;Greece;Spain;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Korea, Republic of |