Obeticholic Acid ( DrugBank: Obeticholic acid )
3 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 93 | Primary biliary cholangitis | 56 |
| 265 | Lipodystrophy | 1 |
| 296 | Biliary atresia | 5 |
93. Primary biliary cholangitis
Clinical trials : 282 / Drugs : 245 - (DrugBank : 56) / Drug target genes : 35 - Drug target pathways : 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 | NCT05239468 (ClinicalTrials.gov) | February 2022 | 28/1/2022 | Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Patients With PBC | A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis | Primary Biliary Cholangitis | Drug: Bezafibrate 100 MG;Drug: Bezafibrate 200 MG;Drug: Obeticholic Acid 5 MG;Drug: Obeticholic Acid placebo;Drug: Bezafibrate Placebo | Intercept Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States |
| 2 | 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 |
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 |
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 |
| 24 | 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 | ||
| 25 | 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 | |||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | 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 | ||
| 40 | 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 |
| 41 | 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 |
| 42 | 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 | Sweden;United Kingdom;Italy;Netherlands;Germany;Australia;Austria;Belgium;Spain;Poland;Canada;United States | ||
| 43 | 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 | ||
| 44 | 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 | ||
| 45 | 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 | ||
| 46 | 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 | ||
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 | ||
| 51 | 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 |
| 52 | 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 | ||
| 53 | 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 | ||
| 54 | 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 | |||
| 55 | 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 | |||
| 56 | 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 |
265. Lipodystrophy
Clinical trials : 116 / Drugs : 170 - (DrugBank : 61) / Drug target genes : 26 - Drug target pathways : 97
| 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 | NCT02430077 (ClinicalTrials.gov) | June 2016 | 24/4/2015 | Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients | Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients | Familial Partial Lipodystrophy | Drug: Obeticholic Acid;Drug: Placebo | University of Texas Southwestern Medical Center | NULL | Active, not recruiting | 18 Years | 70 Years | All | 13 | Phase 2 | United States |
296. Biliary atresia
Clinical trials : 63 / Drugs : 65 - (DrugBank : 37) / Drug target genes : 45 - Drug target pathways : 63
| 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 | EUCTR2014-004693-42-FI (EUCTR) | 02/11/2018 | 20/07/2018 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID | Intercept Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 2 | EUCTR2014-004693-42-NL (EUCTR) | 05/01/2016 | 09/09/2015 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. | A Multicenter, Randomized, Open Label, Single- and Multiple-Dose, Dose Finding Study and Open-Label Extension to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia | Biliary atresia MedDRA version: 18.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 18.0;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | United States;Canada;Germany;Netherlands;United Kingdom | |||
| 3 | EUCTR2014-004693-42-DE (EUCTR) | 06/11/2015 | 01/06/2015 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia- P/0204/2019 | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2014-004693-42-BE (EUCTR) | 27/08/2015 | 26/10/2015 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body including an optional long-term extension. | A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects with Biliary Atresia - ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE) | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 32 | Phase 2 | France;Finland;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 5 | EUCTR2014-004693-42-GB (EUCTR) | 29/06/2015 | 23/12/2014 | A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body. | A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia | Biliary atresia MedDRA version: 20.0;Level: LLT;Classification code 10004653;Term: Biliary atresia;System Organ Class: 100000004850 MedDRA version: 20.1;Classification code 10004654;Term: Biliary atresia, congenital;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OCA 1.5mg Product Code: OCA INN or Proposed INN: obeticholic acid Trade Name: Ocaliva Product Name: OCA 5mg Product Code: OCA INN or Proposed INN: obeticholic acid Product Name: OCA 0.1 mg Product Code: OCA INN or Proposed INN: obeticholic acid Other descriptive name: OBETICHOLIC ACID | Intercept Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Finland;Belgium;Netherlands;Germany;Italy;United Kingdom |