93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details


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

  
5 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2019-004941-34-IT
(EUCTR)
13/04/202104/06/2021A 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 - NA 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]
GENFITNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany
2EUCTR2019-004941-34-FR
(EUCTR)
30/11/202009/10/2020A 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 3United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany
3EUCTR2019-004941-34-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 3United States;Spain;Turkey;Chile;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany
4NCT04526665
(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: PlaceboGenfitNULLActive, not recruiting18 Years75 YearsAll150Phase 3United States;Argentina;Belgium;Brazil;Canada;Chile;France;Germany;Italy;South Africa;Spain;Switzerland;Turkey;United Kingdom
5NCT03124108
(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