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 | NCT03678480 (ClinicalTrials.gov) | March 1, 2021 | 18/9/2018 | A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC) | A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC) | Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract Diseases;Digestive System Diseases;Adolescent | Drug: HTD1801;Drug: Ursodeoxycholic Acid | HighTide Biopharma Pty Ltd | NULL | Withdrawn | 12 Years | 17 Years | All | 0 | Phase 2 | NULL |
| 3 | 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 | ||
| 4 | NCT03516006 (ClinicalTrials.gov) | January 2017 | 20/9/2017 | Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Intra-arterial Injection of Umbilical Cord Mesenchymal Stem Cells in Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: UCMSC;Drug: UDCA | Fuzhou General Hospital | NULL | Active, not recruiting | 18 Years | 65 Years | All | 20 | Phase 1/Phase 2 | NULL |
| 5 | EUCTR2015-003310-24-SE (EUCTR) | 09/10/2015 | 01/09/2015 | Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) | A Phase 3, Open-label, Randomized, Prospective Clinical Trial Evaluating the Efficacy of Stratified Treatment with Ursodeoxycholic Acid (UDCA) in Preventing Hepatobiliary and Colorectal Malignancy in Surveillance Patients with Primary Sclerosing Cholangitis (PSC) - UDCAPSCSURV | Primary sclerosing cholangitis with or without concomitant inflammatory bowel disease included in an unlimited surveillance program for hepatobiliary and colorectal malignancy;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Ursofalk Product Name: Ursofalk | Sahlgrenska Academy | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Sweden | ||
| 6 | NCT01456468 (ClinicalTrials.gov) | October 2011 | 14/10/2011 | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis | Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis - A Human Pilot Study | Cholangitis, Sclerosing | Drug: Oral all-trans retinoic acid (ATRA) | Yale University | Mayo Clinic | Completed | 18 Years | 80 Years | Both | 19 | Phase 1 | United States |
| 7 | NCT01088607 (ClinicalTrials.gov) | October 2010 | 12/3/2010 | Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis | Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis: A Pilot Withdrawal/Reinstitution Trial | Primary Sclerosing Cholangitis | Drug: ursodeoxycholic acid (UDCA) | University of Tennessee | Icahn School of Medicine at Mount Sinai;Ann & Robert H Lurie Children's Hospital of Chicago;University of Colorado, Denver;University of California, San Francisco;University of Pittsburgh;Phoenix Children's Hospital;Children's Hospital of Philadelphia;Children's Healthcare of Atlanta;Children's Hospital Los Angeles;Texas Children's Hospital;Yale University | Completed | 5 Years | 21 Years | All | 27 | Phase 1 | United States;Canada |
| 8 | NCT00059202 (ClinicalTrials.gov) | April 2003 | 21/4/2003 | Trial of High-dose Urso in Primary Sclerosing Cholangitis | Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis | Sclerosing Cholangitis | Drug: Ursodeoxycholic Acid | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NULL | Completed | 18 Years | 75 Years | Both | 150 | Phase 2/Phase 3 | United States |