94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details


臨床試験数 : 142 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2019-000204-14-AT
(EUCTR)
13/12/201926/06/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor inNon-Cirrhotic Subjects with Primary Sclerosing Cholangitis. Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
421Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden
2EUCTR2019-000204-14-DK
(EUCTR)
08/11/201908/07/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
421Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Japan;New Zealand;Sweden
3EUCTR2019-000204-14-FR
(EUCTR)
26/09/201902/08/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without Cirrhosis A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis. Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-9674
INN or Proposed INN: cilofexor
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden
4EUCTR2019-000204-14-FI
(EUCTR)
11/09/201924/06/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
421Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Japan;New Zealand;Sweden
5EUCTR2019-000204-14-ES
(EUCTR)
29/08/201912/09/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 inNon-Cirrhotic Subjects with Primary Sclerosing Cholangitis. Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden
6EUCTR2019-000204-14-GB
(EUCTR)
15/07/201927/06/2019A study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Product Name: Cilofexor
Product Code: GS-9674
INN or Proposed INN: Cilofexor
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Japan;New Zealand;Sweden
7EUCTR2016-002442-23-AT
(EUCTR)
31/01/201721/12/2016An investigational study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-9674
INN or Proposed INN: Not available
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: not available
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom;Austria;Canada;United States
8EUCTR2016-002442-23-GB
(EUCTR)
09/01/201716/11/2016An investigational study to assess the safety and efficacy of a new investigational drug in subjects with Primary Sclerosing Cholangitis Without CirrhosisA Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects with Primary Sclerosing Cholangitis Without Cirrhosis Primary Sclerosing Cholangitis
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Code: GS-9674
INN or Proposed INN: Not available
Other descriptive name: GS-9674
Product Code: GS-9674
INN or Proposed INN: Not available
Other descriptive name: GS-9674
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Canada;Austria;United Kingdom
9NCT02808312
(ClinicalTrials.gov)
July 13, 201617/6/2016Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic FunctionA Phase 1 Open-Label, Parallel-Group, Adaptive, Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9674 in Subjects With Normal and Impaired Hepatic FunctionNonalcoholic Steatohepatitis (NASH);Primary Sclerosing Cholangitis (PSC)Drug: CilofexorGilead SciencesNULLCompleted18 YearsN/AAll57Phase 1United States;New Zealand