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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004941-34-IT (EUCTR) | 13/04/2021 | 04/06/2021 | 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 Acid | 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 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] | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany | ||
| 2 | EUCTR2019-004941-34-FR (EUCTR) | 30/11/2020 | 09/10/2020 | 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 Acid | 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 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 | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany | ||
| 3 | EUCTR2019-004941-34-BE (EUCTR) | 09/10/2020 | 31/08/2020 | 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 Acid | 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 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 | GENFIT | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Turkey;Chile;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany | ||
| 4 | NCT04526665 (ClinicalTrials.gov) | September 24, 2020 | 21/8/2020 | Study 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 Acid | Primary Biliary Cirrhosis | Drug: Elafibranor 80mg;Drug: Placebo | Genfit | NULL | Active, not recruiting | 18 Years | 75 Years | All | 150 | Phase 3 | United States;Argentina;Belgium;Brazil;Canada;Chile;France;Germany;Italy;South Africa;Spain;Switzerland;Turkey;United Kingdom |
| 5 | EUCTR2016-003817-80-FR (EUCTR) | 09/05/2018 | 08/03/2018 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United States;France;Spain;Germany;United Kingdom | ||
| 6 | EUCTR2016-003817-80-GB (EUCTR) | 31/05/2017 | 08/03/2017 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A 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: 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Spain;Germany;United Kingdom | ||
| 7 | EUCTR2016-003817-80-ES (EUCTR) | 22/05/2017 | 08/03/2017 | Phase 2 Efficacy & Safety Study of Elafibranor in patients with PBC | A 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | France;United States;Spain;Germany;United Kingdom | ||
| 8 | NCT03124108 (ClinicalTrials.gov) | April 5, 2017 | 28/3/2017 | Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid | A 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 Acid | Primary Biliary Cholangitis (PBC) | Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo | Genfit | NULL | Completed | 18 Years | 75 Years | All | 45 | Phase 2 | United States;France;Germany;Spain;United Kingdom |