NorUDCA (Norursodeoxycholic acid) ( DrugBank: norUrsodeoxycholic acid )

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1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
94	原発性硬化性胆管炎	1

94. 原発性硬化性胆管炎

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臨床試験数 : 148 /  薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-003367-19-IT (EUCTR)	22/10/2018	05/01/2021	A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis	Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - NUC-5/PSC	Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Norursodeoxycholic acid Product Code: [NorUDCA] INN or Proposed INN: ACIDO DEOSSICOLICO Other descriptive name: NorUDCA (Norursodeoxycholic acid)	DR. FALK PHARMA GMBH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300	Phase 3	Finland;Ireland;Lithuania;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden