| Trial ID: | L0680 |
| Source ID: | EUCTR2009-012916-41-DE
|
| Associated Drug: |
Deferasirox
|
| Title: |
The Impact of Deferasirox on Non-Alcoholic-Steatohepatitis (NASH) - a prospective open-label phase I/II trial - DEFINE
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
To assess the clinical and biological activity of Deferasirox in patients with NASH and increased iron storage / disturbed distribution of iron on liver function and liver histology <br>MedDRA version: 14.0
Level: LLT
Classification code 10053219
Term: No
|
| Interventions: |
<br>Trade Name: Exjade<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: DEFERASIROX<br>CAS Number: 201530-41-8<br>Current Sponsor code: ICL670<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 125-<br><br>T
|
| Outcome Measures: |
Main Objective: For phase I:<br>Safety and tolerability of deferasirox over 12 weeks of continued treatment in two dose escalating cohorts<br><br>For phase II:<br>Changes in liver histology at 48 weeks of treatment with Deferasirox: a decrease in the NASH activity score (NAS) of =1 compared to baseline will be classified as response, an unchanged score or an increase in NAS will be judged as non-response. Deferasirox will be regarded as active in NASH, if = 33% of patients will have a decrease in NAS of = 1 at week 48;Secondary Objective: Phase I:<br>-changes in liver enzymes, serum ferritin, and hemoglobin levels<br>-changes in serologically assessed parameters for NASH<br>-changes in hepatic iron content and distribution (immunohistochemistry)<br>-changes in histology based assessment of hepatic steatosis and fibrosis<br>-changes in liver function (13C-breath testing)<br>Phase II:<br>-changes in liver enzymes<br>-changes in serologically assessed parameters for NASH<br>-changes in hepatic iron content and distribution (immunohistochemistry, MRI assessment)<br>-changes in MRI and histology based assessment of hepatic steatosis and fibrosis<br>-changes in liver function (13C-breath testing)<br>-response association with initial HFE/HD63 gene status<br>-changes in metabolic status<br>-changes in body mass index, fat distribution<br>-safety and tolerability of Deferasirox;Primary end point(s): For phase I:<br>Safety and tolerability of deferasirox over 12 weeks of continued treatment in two dose escalating cohorts<br><br>For phase II:<br>Changes in liver histology at 48 weeks of treatment with Deferasirox: a decrease in the NASH activity score (NAS) of =1 compared to baseline will be classified as response, an unchanged score or an increase in NAS will be judged as non-response. Deferasirox will be regarded as active in NASH, if = 33% of patients will have a decrease in NAS of = 1 at week 48;Timepoint(s) of evaluation of this end point: For phase I: 12 weeks<br>For phase II: 48 weeksSecondary end point(s): Phase I:<br>-changes in liver enzymes, serum ferritin, and hemoglobin levels<br>-changes in serologically assessed parameters for NASH<br>-changes in hepatic iron content and distribution (immunohistochemistry)<br>-changes in US based assessments of hepatic steatosis and fibrosis (facultatively, where available)<br>-changes in liver function (13C-breath testing)<br><br>Phase II:<br>additionally:<br>-changes in hepatic iron content and distribution (MRI assessment)<br>-changes in MRI based assessment of hepatic steatosis and fibrosis;Timepoint(s) of evaluation of this end point: For phase I: 12 weeks<br>For phase II: 48 weeks
|
| Sponsor/Collaborators: |
CROLLL GmbH
|
| Gender: |
All
|
| Age: |
|
| Phases: |
Not applicable
|
| Enrollment: |
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Change in liver his
|
| Start Date: |
24/07/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 July 2012
|
| Locations: |
Germany
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012916-41
|
