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
| 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 | NCT04309773 (ClinicalTrials.gov) | April 6, 2021 | 18/10/2019 | Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy | Double Blind, Multicentric, Randomized, Placebo-controlled Trial, Evaluating the Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy | Primary Sclerosing Cholangitis;Cholestasis | Drug: Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy;Drug: Placebo of Bezafibrate in addition to standard UDCA therapy | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | 75 Years | All | 104 | Phase 3 | France |
| 2 | EUCTR2019-001015-23-FR (EUCTR) | 13/05/2020 | 04/06/2020 | Study evaluating the efficacy of bezafibrate for people suffering of primary sclerosing cholangitis | Double blind, multicentric, randomized, placebo-controlled trial, evaluating the efficacy of 24-month of bezafibrate in primary sclerosing cholangitis with persistent cholestasis despite ursodeoxycholic acid therapy - BEZASCLER | Adult patients with primary sclerosing cholangitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée Product Name: bezafibrate Product Code: C10AB02 INN or Proposed INN: BEZAFIBRATE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 104 | Phase 3 | France | ||
| 3 | EUCTR2014-001438-27-ES (EUCTR) | 29/11/2017 | 10/10/2017 | The effect of bezafibrate on itch in a subset of liver diseases | The effect of bezafibrate on cholestatic itch - FITCH | Primary biliary cirrhosis (PBC) Primary sclerosing cholangitis (PSC) Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezalip INN or Proposed INN: BEZAFIBRATE | Academic Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 84 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Netherlands | ||
| 4 | NCT02701166 (ClinicalTrials.gov) | February 2016 | 2/3/2016 | The Effect of Bezafibrate on Cholestatic Itch | The Effect of Bezafibrate on Cholestatic Itch | Primary Biliary Cholangitis;Primary Sclerosing Cholangitis;Secondary Sclerosing Cholangitis | Drug: Bezafibrate;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Erasmus Medical Center;University Medical Center Groningen;Leiden University Medical Center;UMC Utrecht;Radboud University;Maastricht University Medical Center;Free University Medical Center;University of Barcelona;Ludwig-Maximilians - University of Munich;Friedrich-Alexander-Universität Erlange-Nürnberg;Istituto Clinico Humanitas | Recruiting | 18 Years | N/A | Both | 84 | Phase 3 | Netherlands;Spain |
| 5 | EUCTR2014-001438-27-NL (EUCTR) | 19/08/2015 | 20/07/2015 | The effect of bezafibrate on itch in a subset of liver diseases | The effect of bezafibrate on cholestatic itch - FITCH | Primary biliary cirrhosis (PBC)Primary sclerosing cholangitis (PSC)Secondary sclerosing cholangitis (SSC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bezalip | Academic Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 84 | Netherlands |