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 | 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 | 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 | 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] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 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 | 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 | 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 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 | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 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 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 | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 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 | 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 | 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] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 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 | 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 | 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] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 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 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 | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | 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 | 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 | 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] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 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 | 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 | 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 | 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 | 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] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 11 | EUCTR2007-004040-70-ES (EUCTR) | 01/10/2008 | 01/08/2008 | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(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 | Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(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 | Pacientes con cirrosis biliar primaria con riesgo de progresíon de la enfermedadPatients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 12 | EUCTR2007-004040-70-SE (EUCTR) | 22/09/2008 | 02/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | 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 | 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: 17.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 13 | EUCTR2007-004040-70-FR (EUCTR) | 09/09/2008 | 09/06/2008 | 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 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 | Patients with Primary Biliary Cirrhosis at risk of disease progression MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 183 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden | ||
| 14 | EUCTR2008-001524-31-DE (EUCTR) | 26/08/2008 | 11/07/2008 | 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 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 | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | ||
| 15 | EUCTR2007-004040-70-NL (EUCTR) | 11/08/2008 | 23/06/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | 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 | 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] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 16 | EUCTR2007-004040-70-DE (EUCTR) | 15/05/2008 | 14/03/2008 | Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosis | 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 | 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] | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Ursofalk INN or Proposed INN: URSODEOXYCHOLIC ACID | 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 | ||
| 17 | EUCTR2006-003712-22-DE (EUCTR) | 23/10/2006 | 18/09/2006 | Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers | Pharmacokinetics of UDCA in serum and bile in patients with early stage PBC (stage I-III) and in healthy volunteers | Primary Biliary Cirrhosis Stage I-III MedDRA version: 12.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® 500 mg Filmtabletten Product Name: Ursofalk® 500 mg Filmtabletten INN or Proposed INN: Ursodeoxycholic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany |