Gft505    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
93Primary biliary cholangitis [Primary biliary cirrhosis (~Mar 2017)]3

93. Primary biliary cholangitis [Primary biliary cirrhosis (~Mar 2017)]    [ 230 clinical trials,   215 drugs,   (DrugBank: 51 drugs),   34 drug target genes,   107 drug target pathways]
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
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Inclusion_
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Target_
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PhaseCountries
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
2EUCTR2016-003817-80-FR
(EUCTR)
09/05/201808/03/2018Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBCA Multicenter, Double-Blind, Randomized, 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 Acid Primary biliary cholangitis
MedDRA version: 20.0;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
Product Name: Elafibranor
Product Code: GFT505
INN or Proposed INN: Elafibranor
Genfit SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;France;Spain;Germany;United Kingdom
3EUCTR2016-003817-80-ES
(EUCTR)
22/05/201708/03/2017Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBCA Multicenter, Double-Blind, Randomized, 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 (PBC) and Inadequate Response to Ursodeoxycholic Acid Primary biliary cholangitis
MedDRA version: 19.1;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
Product Name: Elafibranor
Product Code: GFT505
INN or Proposed INN: Elafibranor
Genfit SANULLNot RecruitingFemale: yes
Male: yes
45Phase 2France;United States;Spain;Germany;United Kingdom