93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
| 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 | EUCTR2017-003528-62-BE (EUCTR) | 11/01/2019 | 24/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 2 | EUCTR2017-003528-62-DE (EUCTR) | 05/12/2018 | 16/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 3 | EUCTR2017-003528-62-NL (EUCTR) | 29/11/2018 | 09/07/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | United States;France;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;United Kingdom | ||
| 4 | EUCTR2017-003528-62-AT (EUCTR) | 19/10/2018 | 25/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Australia;Austria;Netherlands;Germany;United Kingdom | ||
| 5 | EUCTR2017-003528-62-ES (EUCTR) | 28/08/2018 | 24/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 6 | EUCTR2017-003528-62-GB (EUCTR) | 27/07/2018 | 22/05/2018 | A Phase 2 clinical study evaluating safety and efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) without adequate response or intolerance to Ursodeoxycholic Acid (UDCA). | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis (PBC) with or without an Inadequate Response to Ursodeoxycholic Acid (UDCA). - INTREPID | Primary Biliary Cholangitis (PBC) MedDRA version: 20.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 Product Name: EDP-305 Product Code: EDP-305 INN or Proposed INN: EDP-305 | Enanta Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 119 | Phase 2 | France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom | ||
| 7 | NCT03394924 (ClinicalTrials.gov) | December 27, 2017 | 23/12/2017 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis | A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis (PBC) With or Without an Inadequate Response to Ursodeoxycholic Acid (UDCA) | Primary Biliary Cholangitis | Drug: EDP-305 Dose 1;Drug: EDP-305 Dose 2;Drug: Placebo | Enanta Pharmaceuticals | Pharmaceutical Research Associates;Triangle Biostatistics | Completed | 18 Years | 75 Years | All | 68 | Phase 2 | United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom |