ELAFIBRANOR ( 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 | 8 |
| 94 | 原発性硬化性胆管炎 | 2 |
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
Showing 1 to 8 of 8 diseases
| 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 t ... | 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 A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate t ... | 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] Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;S ... | 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 United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Bra ... | ||
| 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 t ... | 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 t ... | 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] Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;S ... | 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 United States;Spain;Turkey;Chile;United Kingdom;Italy;Switzerland;France;Mexico;Canada;Argentina;Bel ... | ||
| 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 t ... | 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 t ... | 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] Primary Biliary Cholangitis MedDRA version: 21.0;Level: LLT;Classification code 10034176;Term: PBC;S ... | 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 United States;Spain;Turkey;Chile;Italy;United Kingdom;Switzerland;France;Mexico;Canada;Argentina;Bel ... | ||
| 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 A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate ... | 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 United States;Argentina;Belgium;Brazil;Canada;Chile;France;Germany;Italy;South Africa;Spain;Switzerl ... |
| 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 A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy ... | 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] Primary biliary cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10034176;Term: PBC;S ... | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibran ... | 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 A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy ... | 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] Primary biliary cholangitis MedDRA version: 20.0;Level: LLT;Classification code 10034176;Term: PBC;S ... | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibran ... | 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 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | 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 A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy ... | 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] Primary biliary cholangitis MedDRA version: 19.1;Level: LLT;Classification code 10034176;Term: PBC;S ... | Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibranor Product Code: GFT505 INN or Proposed INN: Elafibranor Product Name: Elafibran ... | 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 Study to Evaluate the Efficacy and Safety of Elafibranorin Patients With Primary Biliary Cholangitis ... | 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 A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy ... | 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 |
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
Showing 1 to 2 of 2 diseases
| 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 | EUCTR2022-002695-37-ES (EUCTR) | 13/02/2023 | 10/01/2023 | A study on safety and efficacy of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis (PSC) A study on safety and efficacy of Elafibranorin Adult Participants with Primary Sclerosing Cholangit ... | 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) A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open-Label Long Term ... | Adults patients with Primary Sclerosing Cholangitis (PSC) MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] Adults patients with Primary Sclerosing Cholangitis (PSC) MedDRA version: 20.1;Level: LLT;Classifica ... | Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor Product Code: IPN60190; GFT505 INN or Proposed INN: Elafibranor Product Code: IPN60190; GFT505 INN or P ... | Ipsen Bioscience, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Canada;United States;Italy;United Kingdom;France;Portugal;Germany;Spain | ||
| 2 | NCT05627362 (ClinicalTrials.gov) | January 27, 2023 | 22/11/2022 | A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis. A Study to Assess Safety and Effectiveness of Elafibranorin Adult Participants With Primary Sclerosi ... | 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). A Phase II, Multicenter, Double-Blind, Randomised, Placebo-Controlled Study and Open Label Long Term ... | Primary Sclerosing Cholangitis | Drug: Elafibranor 80 mg;Drug: Elafibranor 120 mg;Drug: Placebo Matched to Elafibranor 80 mg;Drug: Placebo Matched to Elafibranor 120 mg Drug: Elafibranor80 mg;Drug: Elafibranor120 mg;Drug: Placebo Matched to Elafibranor80 mg;Drug: Place ... | Ipsen | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | United States |