ACIDO DEOSSICOLICO ( DrugBank: - )


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


臨床試験数 : 142 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
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