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The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis

NCT01278056 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-07-20

No results posted yet for this study

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

DRUG

Exjade

Two dose escalating cohorts of oral administration in Phase I. Phase II: oral administration of the maximum tolerated dose.

Sponsors & Collaborators

  • Estimate, GmbH

    collaborator INDUSTRY

  • University of Magdeburg

    collaborator OTHER

  • Crolll Gmbh

    lead OTHER

Principal Investigators

  • Gerhard Treiber, PD Dr. med.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01278056 on ClinicalTrials.gov