94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details


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

  
1 trial found
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1EUCTR2016-003367-19-IT
(EUCTR)
22/10/201805/01/2021A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Finland;Ireland;Lithuania;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden