Elafibranor 80 mg    (DrugBank: Elafibranor)

1 disease
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[原発性胆汁性肝硬変 (~2017.3)]3

93. 原発性胆汁性胆管炎[原発性胆汁性肝硬変 (~2017.3)] [臨床試験数:230,薬物数:215(DrugBank:51),標的遺伝子数:34,標的パスウェイ数:107
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
3 / 230 trials found
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1EUCTR2019-004941-34-BE
(EUCTR)
09/10/202031/08/2020A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic AcidA Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid Primary Biliary Cholangitis
MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Elafibranor
Product Code: GFT505
INN or Proposed INN: ELAFIBRANOR
GENFITNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3Finland;Spain;Turkey;Chile;Russian Federation;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Denmark;South Africa;Germany;Netherlands
2NCT04526665
(ClinicalTrials.gov)
September 24, 202021/8/2020Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic AcidPrimary Biliary CirrhosisDrug: Elafibranor 80mg;Drug: PlaceboGenfitNULLRecruiting18 Years75 YearsAll150Phase 3United States
3NCT03124108
(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