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:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01094158
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically proven NAFLD or NASH based on a biopsy performed during the preceding 18 months fulfilling the following criteria:
* At least 15% of hepatocytes showing steatosis,with Fibrosis of not more than stage 3, with at most bridging fibrosis.
Patients with a NAFLD activity score 0-2 will be considered to have NAFLD. Biopsies with an activity score of 3 or more will be considered NASH.
* Triglycerides concentration in the liver of 6% or more as measured by NMRS.
* At least two elevated serum ALT levels in the previous six months, with latest test within 2 months of trial.
* Normal or only slightly impaired synthetic liver function (serum albumin \>3.5gm%, INR 0.8-1.3)
* Male or female aged 18-75 years.
* Negative pregnancy test at study entry for females of child bearing potential.
* Females of child bearing potential practicing reliable contraception throughout the study period.
* Signature of the written informed consent
Exclusion Criteria:
* Evidence of cirrhosis on liver biopsy.
* Evidence of fibrosis of more than stage 3 on liver biopsy.
* Patient with liver disease due to acute or chronic hepatitis A, B,C, HIV, and all other liver diseases affecting liver function. Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
* BMI \> 35 or \>130 kg body weight
* Any other concomitant, significant: metabolic, infectious, inflammatory, neoplastic, or other non-liver disease.
* Various concomitant diseases requiring chronic steroid administration.
* Use of warfarin, metformin, thiaglitazones, insulin or current steroid therapy of more than 3 days.
* Use of other investigational agents \< 30 days prior to the study.
* Pregnancy
* Daily alcohol intake \> 10gm/day.
* Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent.
* Performance status: WHO performance status ≥4.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01094158
Study Brief:
Protocol Section:
NCT01094158