Bezafilbrate IR ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
93原発性胆汁性胆管炎1

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
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agemin
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PhaseCountries
1EUCTR2018-002575-17-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
Trade Name: Bezalip
Product Name: Bezafilbrate 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;Netherlands;Norway;Germany;Sweden;Korea, Republic of