NCT01278056

The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis

The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis (NASH) - a Prospective Open Label Phase I/II Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Crolll Gmbh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II open-label uncontrolled, prospective study to assess the clinical and biological effects of Deferasirox (ICL 670, Exjade®) in patients with NASH and increased iron storage / distribution of iron on liver function and liver histology. NASH is defined clinically and histologically by elevated liver enzymes, signs of hepatic steatosis on ultrasound and magnetic resonance imaging, impaired liver function as expressed by functional breath tests, and significantly altered liver histology. Patients will be treated in a phase I and phase II part for either 12 or 48 weeks. Both study parts have different endpoints: in phase I the side effect profile will be evaluated while in phase II the therapeutic response will be tested. Accordingly, measures will be different. Approximately 10 patients in phase I and 50 patients in phase II will be enrolled according to sample size calculations. The design is an "adaptive" Two-stage design, allowing to minimize the number of patients included into the trial as well as to introduce corrections for the second stage.

Conditions

• Non-alcoholic Steatohepatitis
• Increased Iron Storage / Disturbed Distribution

Interventions

Type	Name	Description
DRUG	Exjade	Two dose escalating cohorts of oral administration in Phase I. Phase II: oral administration of the maximum tolerated dose.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-07-01
• First posted: 2011-01-17
• Last updated: 2012-07-20

Locations

9 sites across 1 country: Germany