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


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

  
9 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2012-002473-61-BE
(EUCTR)
16/12/201302/09/2013An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 18.0;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-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2France;United States;Canada;Spain;Belgium;Denmark;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
2EUCTR2012-002473-61-NL
(EUCTR)
12/12/201304/10/2013An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 18.1;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-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden
3EUCTR2012-002473-61-SE
(EUCTR)
26/06/201320/03/2013An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 18.0;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-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden
4EUCTR2012-002473-61-ES
(EUCTR)
21/06/201309/04/2013An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 14.1;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-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden
5EUCTR2012-002473-61-IT
(EUCTR)
18/06/201304/04/2013A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Simtuzumab
Product Code: GS-6624
INN or Proposed INN: Simtuzimab
Product Name: Simtuzimab
Product Code: GS-6624
INN or Proposed INN: Simtuzimab
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
6EUCTR2012-002473-61-GB
(EUCTR)
17/05/201313/03/2013An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 17.0;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-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot Recruiting Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
7EUCTR2012-002473-61-DK
(EUCTR)
14/05/201308/04/2013An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 17.0;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-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2United States;Canada;Belgium;Spain;Denmark;Netherlands;Italy;United Kingdom;Sweden
8EUCTR2012-002473-61-DE
(EUCTR)
08/05/201308/03/2013An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC) Primary Sclerosing Cholangitis (PSC)
MedDRA version: 17.0;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-6624
INN or Proposed INN: GS-6624
INN or Proposed INN: GS-6624
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
225Phase 2France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
9NCT01672853
(ClinicalTrials.gov)
March 4, 201322/8/2012Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects With Primary Sclerosing Cholangitis (PSC)Primary Sclerosing Cholangitis (PSC)Biological: Simtuzumab;Biological: PlaceboGilead SciencesNULLCompleted18 Years70 YearsAll235Phase 2United States;Belgium;Canada;Denmark;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom