93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details


臨床試験数 : 282 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113

  
22 trials found
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1NCT05239468
(ClinicalTrials.gov)
February 202228/1/2022Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Patients With PBCA 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 CholangitisPrimary Biliary CholangitisDrug: Bezafibrate 100 MG;Drug: Bezafibrate 200 MG;Drug: Obeticholic Acid 5 MG;Drug: Obeticholic Acid placebo;Drug: Bezafibrate PlaceboIntercept PharmaceuticalsNULLRecruiting18 YearsN/AAll60Phase 2United States
2EUCTR2018-002575-17-DE
(EUCTR)
09/12/202030/09/2019Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United 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
3NCT04751188
(ClinicalTrials.gov)
October 2, 20205/2/2021A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary CholangitisSafety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without ResponsePrimary Biliary CirrhosisDrug: Bezafibrate 200 MG Oral Tablet;Drug: Placebo;Drug: Ursodeoxycholic AcidInstituto Mexicano del Seguro SocialNULLActive, not recruiting18 Years65 YearsAll11Phase 3Mexico
4EUCTR2018-002575-17-AT
(EUCTR)
20/07/202007/04/2020Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United 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
5EUCTR2018-002575-17-HR
(EUCTR)
05/06/202025/06/2020Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2United 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
6EUCTR2018-002575-17-PL
(EUCTR)
05/05/202009/01/2020Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;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
7EUCTR2018-002575-17-CZ
(EUCTR)
27/02/202016/10/2019Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;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
8EUCTR2018-002575-17-GR
(EUCTR)
14/02/202005/11/2019Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;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
9EUCTR2018-002575-17-GB
(EUCTR)
14/02/202019/08/2019Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Estonia;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
10EUCTR2018-002575-17-LT
(EUCTR)
17/01/202017/10/2019Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2Czechia;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
11EUCTR2018-002575-17-SK
(EUCTR)
04/12/201920/09/2019Study 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.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United 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
12EUCTR2018-002575-17-ES
(EUCTR)
15/10/201926/07/2019Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2Estonia;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
13EUCTR2018-002575-17-FR
(EUCTR)
14/10/201909/07/2019Study 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.NULLAuthorised-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): noAustria;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
14NCT04594694
(ClinicalTrials.gov)
October 2, 201914/7/2020Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Patients With PBCA 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 AcidPrimary Biliary CholangitisDrug: Obeticholic acid;Drug: Bezafibrate 200 MG;Drug: OCA Placebo;Drug: Bezafibrate 200 mg Placebo;Drug: Bezafibrate 400 MG;Drug: Bezafibrate 400 mg PlaceboIntercept PharmaceuticalsNULLRecruiting18 YearsN/AAll75Phase 2Australia;Austria;Belgium;Croatia;Czechia;Estonia;France;Germany;Greece;Hungary;Ireland;Israel;Korea, Republic of;Lithuania;Netherlands;Norway;Poland;Spain;Sweden;United Kingdom
15EUCTR2018-002575-17-HU
(EUCTR)
25/07/201904/06/2019Study 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.NULLAuthorised-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): noGreece;Finland;Spain;Ireland;Austria;Israel;United Kingdom;France;Hungary;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Korea, Republic of;Sweden
16EUCTR2014-001438-27-ES
(EUCTR)
29/11/201710/10/2017The effect of bezafibrate on itch in a subset of liver diseasesThe 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 CenterNULLNot 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): noSpain;Netherlands
17NCT02937012
(ClinicalTrials.gov)
October 201613/10/2016Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-respondersEfficacy and Security of Bezafibrate in Patients With Primary Biliary Cirrhosis Without Biochemical Response to Ursodeoxycholic Acid: A Randomized, Double-blind, Placebo-controlled TrialPrimary Biliary CirrhosisDrug: Bezafibrate;Drug: Ursodeoxycholic Acid;Drug: Placebo (for Bezafibrate)Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranNULLUnknown status18 Years65 YearsAll34Phase 3Mexico
18NCT02701166
(ClinicalTrials.gov)
February 20162/3/2016The Effect of Bezafibrate on Cholestatic ItchThe Effect of Bezafibrate on Cholestatic ItchPrimary Biliary Cholangitis;Primary Sclerosing Cholangitis;Secondary Sclerosing CholangitisDrug: Bezafibrate;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Erasmus Medical Center;University Medical Center Groningen;Leiden University Medical Center;UMC Utrecht;Radboud University;Maastricht University Medical Center;Free University Medical Center;University of Barcelona;Ludwig-Maximilians - University of Munich;Friedrich-Alexander-Universität Erlange-Nürnberg;Istituto Clinico HumanitasRecruiting18 YearsN/ABoth84Phase 3Netherlands;Spain
19EUCTR2014-001438-27-NL
(EUCTR)
19/08/201520/07/2015The effect of bezafibrate on itch in a subset of liver diseasesThe 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: BezalipAcademic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Netherlands
20NCT01654731
(ClinicalTrials.gov)
October 15, 201230/7/2012Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary CirrhosisMulticenter, Randomized, Double-blind Placebo Controlled Trial of Bezafibrate for the Treatment of Primary Biliary Cirrhosis in Patients With Incomplete Response to Ursodesoxycholic Acid Therapy.PBCDrug: Bezafibrate;Drug: placeboAssistance Publique - Hôpitaux de ParisNULLCompleted18 YearsN/AAll100Phase 3France
21EUCTR2011-004681-15-AT
(EUCTR)
09/11/201119/10/2011Effects of the activation of PPARs in the orphan hepatic disease primary biliary cirrhosisEffects of the activation of peroxisome proliferator-activated receptors in patients with primary biliary cirrhosis - Effects of the activation of PPARs in patients with PBC Up to 67% of PBC patients have an incomplete biochemical response to UDCA and remain at increased risk for progression to cirrhosis and liver-related death. In this study we will prospectively examine the therapeutic effects of bezafibrate (a pan-agonist activating PPARalpha/delta/gamma) in patients with early-stage PBC with a specific focus on improvement of liver functions, inflammation, lipid profile, oxidative status and endothelial function.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Bezafibrat Genericon retard 400 mg
Product Name: Bezafibrat
Product Code: 1-20190
INN or Proposed INN: BEZAFIBRATE
Product Name: Ursodeoxycholsäure
Other descriptive name: URSODEOXYCHOLIC ACID
Medizinische Universität GrazNULLNot RecruitingFemale: yes
Male: yes
Austria
22JPRN-C000000225
2003/12/0113/09/2008Randomized controlled study of ursodeoxycholic acid (UDCA) with or without bezafibrate in primary biliary cirrhosis Primary biliary cirrhosisIntervention:UDCA+Bezafibrate
Bezafibrate: 400mg/day for 12 months
Dose of pretreatment UDCA is not changed after entry.
control:UDCA only
Dose of pretreatment UDCA is not changed after entry.
Gunma Liver Study GroupNULLComplete: follow-up complete20years-old85years-oldMale and Female20Not applicableJapan