Clinical Trial Details
Trial ID: | L0247 |
Source ID: | NCT01278056 |
Associated Drug: | Deferasirox |
Title: | The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis |
Acronym: | DEFINE |
Status: | Completed |
Study Results: | No Results Available |
Results: | -- |
Conditions: | Non-alcoholic Steatohepatitis|Increased Iron Storage / Disturbed Distribution |
Interventions: | Drug: Exjade |
Outcome Measures: | Safety and tolerability of deferasirox in all patients (Phase I)|Changes in liver histology in all patients (Phase II)|Phase I: e.g. changes in liver enzymes, serum ferritin, and hemoglobin levels|Phase II: e.g. changes in MRI and histology based assessment of hepatic steatosis, fibrosis and iron content |
Sponsor/Collaborators: | Crolll Gmbh|Estimate, GmbH|University of Magdeburg |
Gender: | All |
Age: | 18 Years and older ?? (Adult, Older Adult) |
Phases: | Phase 1/Phase 2 |
Enrollment: | 5 |
Study Type: | Interventional |
Study Designs: | Allocation: N/A|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment |
Start Date: | March 2010 |
Completion Date: | July 2012 |
Results First Posted: | -- |
Last Update Posted: | July 20, 2012 |
Locations: | Zollernalbklinikum, Balingen/Hechingen, Germany|Charit??, Virchow Klinikum, Berlin, Germany|Klinikum der J. W. Goethe-Universit??t, Med. Klinik I, Frankfurt, Germany|Universit??tsklinikum Halle, Klinik & Poliklinik f??r Innere Medizin I, Halle, Germany|Universit??tsklinikum des Saarlandes, Homburg/Saar, Germany|Universit??tsklinikum Magdeburg, Klinik f??r Gastroenterologie, Hepatologie und Infektiologie, Magdeburg, Germany|Universit??tsklinikum Mainz, I. Medizinische Klinik und Poliklinik, Mainz, Germany|Universit??tsklinikum Regensburg, Klinik und Poliklinik f??r Innere Med. I, Regensburg, Germany|Universit??tsklinikum T??bingen, Medizinische Klinik IV, T??bingen, Germany |
URL: | https://ClinicalTrials.gov/show/NCT01278056 |