93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 | ||
| 2 | EUCTR2018-002575-17-AT (EUCTR) | 20/07/2020 | 07/04/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 3 | EUCTR2018-002575-17-HR (EUCTR) | 05/06/2020 | 25/06/2020 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as PBC). | A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary BiliaryCholangitis Who Had an Inadequate Response or Who Were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) MedDRA version: 21.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip mono | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2 | United States;Estonia;Slovakia;Greece;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Croatia;Australia;Denmark;Norway;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | EUCTR2018-002575-17-FR (EUCTR) | 14/10/2019 | 09/07/2019 | Study to determine if the investigational drug obeticholic acid (also known as OCA) in combination with the investigational drug bezafibrate (BZF), has an effect on Primary Biliary Cholangitis (also known as Primary Biliary Cirrhosis or PBC). | A Phase 2, Double-Blind, Randomized, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid, Administered Alone or in Combination with Bezafibrate, in Subjects with Primary Biliary Cholangitis who had an Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid | Primary Biliary Cholangitis (PBC) in patients with Inadequate Response or who were Unable to Tolerate Ursodeoxycholic Acid MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Ocaliva 10mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Ocaliva 5mg Product Name: Obeticholic Acid Product Code: INT-747, OCA INN or Proposed INN: obeticholic acid Other descriptive name: 6 alpha-ethylchenodeoxycholic acid (6-EDCA), OCA, INT-747 Trade Name: Bezalip Product Name: Bezafibrate IR INN or Proposed INN: BEZAFIBRATE Other descriptive name: Bezafibrate, Beza, BZF, Bezalip Trade Name: Bezalip mono Product Name: Bezafibrate SR | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Norway;Sweden;Lithuania;Finland;Slovenia;Korea, Republic of;Netherlands;Latvia;Australia;Denmark;France;Israel;Ireland;Spain;Greece;Slovakia;Estonia | ||
| 12 | 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 | |
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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;Italy;Switzerland;United Kingdom;Hungary;Argentina;Belgium;Brazil;Australia;Germany | ||
| 16 | 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 | ||
| 17 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Phase 4 | United States;Estonia;Spain;Lithuania;Italy;Switzerland;United Kingdom;Hungary;Argentina;Brazil;Belgium;Australia;Germany | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Serbia;Portugal;United States;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;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Sweden | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 |