The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
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.