Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT01278056
Eligibility Criteria:
Inclusion Criteria (shortened):
* Patients with elevated liver enzymes
* Elevated serum ferritin (females \> 300 ng/ml, males \> 450 ng/ml)
* Liver Histology consistent with a diagnosis of NASH
Exclusion Criteria (shortened):
* Alcohol intake \> 140 g/week
* Established liver cirrhosis Child Pugh B or C
* Copresence of other causes of chronic liver disease
* Anemia \< 10 g/dl
* Any elevation of liver enzymes \> 5 ULN (ALAT, ASAT, g-GT), \> 2.5 ULN (other), \> 1.5 (Bilirubin)
* Serum creatinine \> 1.4 mg/dl or Ccr \< 60 ml/min
* Hemochromatosis
* Known allergy or contraindication to the administration of Deferasirox
* Sexually active pre-menopausal female patients who are unable to use a highly effective method of birth control. An exception is made for those who have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation.
* Patients with impaired coagulation
* History of blood transfusion during the 6 months prior to study entry
* Oral iron supplementation within the last 4 weeks of study entry
* Treatment with phlebotomy within 2 weeks of screening visit
* Desferal treatment within 1 month of the screening visit
* Patients currently or previously treated with deferiprone or Deferasirox
* Presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug
* Positive HIV serology
* Patients with active inflammatory diseases that may interfere with the accurate measurement of serum ferritin
* Patients with a diagnosis of a clinically relevant cataract or a previous history of clinically relevant ocular toxicity related to iron chelation
* Pregnant or breast feeding patients
* Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug within 7 days prior to the screening visit
* Medications with proven or suspected influence on NASH such as glitazones, statins, or metformin are no exclusion criteria for study entry (insulin is not regarded to interfere with NASH).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01278056
Study Brief:
Protocol Section:
NCT01278056