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 | EUCTR2020-001961-34-PL (EUCTR) | 24/02/2021 | 18/11/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Belgium;Poland;Netherlands;Germany;United Kingdom | ||
| 2 | EUCTR2020-001961-34-SK (EUCTR) | 24/02/2021 | 02/10/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 3 | EUCTR2020-001961-34-DE (EUCTR) | 02/02/2021 | 14/09/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Poland;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2020-001961-34-IT (EUCTR) | 25/01/2021 | 24/05/2021 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-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 GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Czechia;Hungary;Slovakia;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 5 | EUCTR2020-001961-34-NL (EUCTR) | 15/12/2020 | 08/10/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Belgium;Germany;Netherlands;United Kingdom | ||
| 6 | EUCTR2020-001961-34-BE (EUCTR) | 11/12/2020 | 23/10/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary;Slovakia;Belgium;Netherlands;Germany;United Kingdom | ||
| 7 | EUCTR2020-001961-34-HU (EUCTR) | 16/11/2020 | 17/09/2020 | Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary Cholangitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 2 | Hungary |