EDP-305 ( DrugBank: - )


1 disease
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7

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
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2017-003528-62-BE
(EUCTR)
11/01/201924/05/2018A 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.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2Canada;Austria;Netherlands;Belgium;United States;United Kingdom;Australia;France;Germany;Spain
2EUCTR2017-003528-62-DE
(EUCTR)
05/12/201816/05/2018A 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.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2United States;France;Canada;Spain;Belgium;Austria;Australia;Netherlands;Germany;United Kingdom
3EUCTR2017-003528-62-NL
(EUCTR)
29/11/201809/07/2018A 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.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2United States;France;Canada;Spain;Belgium;Austria;Australia;Germany;Netherlands;United Kingdom
4EUCTR2017-003528-62-AT
(EUCTR)
19/10/201825/05/2018A 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.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2Canada;Austria;Netherlands;Belgium;United States;United Kingdom;Australia;France;Germany;Spain
5EUCTR2017-003528-62-ES
(EUCTR)
28/08/201824/05/2018A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
6EUCTR2017-003528-62-GB
(EUCTR)
27/07/201822/05/2018A 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.NULLNot RecruitingFemale: yes
Male: yes
119Phase 2France;United States;Canada;Belgium;Spain;Austria;Australia;Netherlands;Germany;United Kingdom
7NCT03394924
(ClinicalTrials.gov)
December 27, 201723/12/2017A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary CholangitisA 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 CholangitisDrug: EDP-305 Dose 1;Drug: EDP-305 Dose 2;Drug: PlaceboEnanta PharmaceuticalsPharmaceutical Research Associates;Triangle BiostatisticsCompleted18 Years75 YearsAll68Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Netherlands;Spain;United Kingdom