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

  
7 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
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PhaseCountries
1EUCTR2020-001961-34-SK
(EUCTR)
24/02/202102/10/2020Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Hungary;Slovakia;Poland;Belgium;Netherlands;Germany;United Kingdom
2EUCTR2020-001961-34-PL
(EUCTR)
24/02/202118/11/2020Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Hungary;Slovakia;Belgium;Poland;Netherlands;Germany;United Kingdom
3EUCTR2020-001961-34-DE
(EUCTR)
02/02/202114/09/2020Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Hungary;Slovakia;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom
4EUCTR2020-001961-34-IT
(EUCTR)
25/01/202124/05/2021Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 20.0;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
Product Code: [RhuDex choline salt]
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
Product Code: [RhuDex choline salt]
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
Product Code: [RhuDex choline salt]
INN or Proposed INN: RhuDex choline salt
DR. FALK PHARMA GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Czechia;Hungary;Slovakia;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy
5EUCTR2020-001961-34-NL
(EUCTR)
15/12/202008/10/2020Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Hungary;Slovakia;Belgium;Germany;Netherlands;United Kingdom
6EUCTR2020-001961-34-BE
(EUCTR)
11/12/202023/10/2020Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Hungary;Slovakia;Belgium;Netherlands;Germany;United Kingdom
7EUCTR2020-001961-34-HU
(EUCTR)
16/11/202017/09/2020Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisDouble-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis - RhuDex vs placebo in PBC Primary biliary cholangitis
MedDRA version: 21.0;Level: PT;Classification code 10080429;Term: Primary biliary cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: RhuDex 25 mg (31.75 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 50 mg (63.5 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Product Name: RhuDex 100 mg (127 mg RhuDex choline salt) granules
INN or Proposed INN: RhuDex choline salt
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 2Hungary