Bezalip ( DrugBank: - )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 93 | 原発性胆汁性胆管炎 | 14 |
| 94 | 原発性硬化性胆管炎 | 2 |
| 160 | 先天性魚鱗癬 | 1 |
93. 原発性胆汁性胆管炎
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 | 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 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 | ||
| 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 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 | ||
| 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 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 |
94. 原発性硬化性胆管炎
臨床試験数 : 148 / 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141
| 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 | 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 | ||
| 2 | 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 |
160. 先天性魚鱗癬
臨床試験数 : 42 / 薬物数 : 71 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 112
| 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 | EUCTR2011-001205-27-NL (EUCTR) | 04/08/2011 | 25/07/2011 | The effect of lipid lowering medication on lipid accumulation in patients with neutral lipid storage disease with muscle weakness. | The effect of fibrate therapy in two patients with neutral lipid storage disease with myopathy (NLSDM). - Fibrate Trail | Neutral lipid storage disease with myopathy MedDRA version: 13.1;Level: PT;Classification code 10007636;Term: Cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 13.1;Level: HLGT;Classification code 10013317;Term: Lipid metabolism disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1;Classification code 10028641;Term: Myopathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Bezalip Retard Product Name: Bezalip Retard Product Code: RVG 18388 INN or Proposed INN: BEZAFIBRATE Other descriptive name: none | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: no | Netherlands |