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

  
2 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2014-002205-38-IT
(EUCTR)
02/12/201512/02/2018A Study of Obeticholic Acid (OCA) in Patients with Primary Sclerosing CholangitisA Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis - AESOP (Assessment of Efficacy and Safety of OCA in PSC) Primary Sclerosing Cholangitis
MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: OCA 1,5 mg
Product Code: INT-747, OCA
INN or Proposed INN: ACIDO OBETICOLICO
Other descriptive name: ACIDO OBETICOLICO
Product Name: OCA 5 mg
Product Code: INT-747, OCA
INN or Proposed INN: ACIDO OBETICOLICO
Other descriptive name: ACIDO OBETICOLICO
INTERCEPT PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
75Phase 2United States;Italy
2NCT02177136
(ClinicalTrials.gov)
February 9, 201526/6/2014Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Primary Sclerosing CholangitisPrimary Sclerosing Cholangitis (PSC)Drug: OCA;Drug: PlaceboIntercept PharmaceuticalsNULLCompleted18 Years75 YearsAll77Phase 2United States;Italy;Austria;Belgium;France;Germany;Netherlands;Norway;Sweden;United Kingdom