Elafibranor 120 mg ( DrugBank: Elafibranor )


2 diseases
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
94原発性硬化性胆管炎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_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03124108
(ClinicalTrials.gov)
April 5, 201728/3/2017Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic AcidA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg After 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis and Inadequate Response to Ursodeoxycholic AcidPrimary Biliary Cholangitis (PBC)Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: PlaceboGenfitNULLCompleted18 Years75 YearsAll45Phase 2United States;France;Germany;Spain;United Kingdom

94. 原発性硬化性胆管炎


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05627362
(ClinicalTrials.gov)
January 27, 202322/11/2022A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term Extension to Evaluate the Safety and Efficacy of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis (PSC).Primary Sclerosing CholangitisDrug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo Matched to Elafibranor 80 mg;Drug: Placebo Matched to Elafibranor 120 mgIpsenNULLRecruiting18 Years75 YearsAll60Phase 2United States