93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
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
Showing 1 to 10 of 17 diseases
| 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 | EUCTR2007-004040-70-PL (EUCTR) | 30/04/2013 | 20/03/2013 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursod ... | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP le ... | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: UR ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherland ... | ||
| 2 | NCT01857284 (ClinicalTrials.gov) | September 2009 | 16/5/2013 | Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalkin the Treatment of Adult Primary Bi ... | A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult Primary Biliary Cirrhosis A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to In ... | Primary Biliary Cirrhosis | Drug: Tauroursodeoxycholic Acid Capsules;Drug: Ursodeoxycholic Acid Capsules | Beijing Friendship Hospital | Beijing Trendful Kangjian Medical Information Consulting Limited Company | Completed | 18 Years | 70 Years | Both | 216 | Phase 3 | China |
| 3 | EUCTR2007-004040-70-GB (EUCTR) | 01/06/2009 | 19/08/2008 | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LL ... | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: UR ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlan ... | ||
| 4 | EUCTR2007-004040-70-AT (EUCTR) | 19/03/2009 | 23/06/2008 | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LL ... | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: UR ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 183 | Phase 3 | Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlan ... | ||
| 5 | EUCTR2007-004040-70-DK (EUCTR) | 29/01/2009 | 19/11/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursod ... | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP le ... | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: UR ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Ne ... | ||
| 6 | EUCTR2007-004040-70-LT (EUCTR) | 22/12/2008 | 16/09/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursod ... | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP le ... | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: UR ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Ne ... | ||
| 7 | EUCTR2008-001524-31-NL (EUCTR) | 26/11/2008 | 17/07/2008 | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the ... | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the ... | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;T ... | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | ||
| 8 | EUCTR2007-004040-70-FI (EUCTR) | 10/11/2008 | 25/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursod ... | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP le ... | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: UR ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Ne ... | ||
| 9 | NCT01510860 (ClinicalTrials.gov) | November 2008 | 12/1/2012 | Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis UrsofalkTablets (500 mg) Versus UrsofalkCapsules (250 mg) in the Treatment of Primary Biliary Cirrho ... | Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the ... | Primary Biliary Cirrhosis | Drug: UDCA (Ursodeoxycholic acid) | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | N/A | All | 65 | Phase 4 | Germany |
| 10 | EUCTR2007-004040-70-HU (EUCTR) | 18/10/2008 | 04/08/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursod ... | Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the co ... | PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver MedDRA version: 14.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP le ... | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: UR ... | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Ne ... |