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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT01680003
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant females age 18 years or older
* Written informed consent obtained from patient or parents/ guardian
* Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range
* Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial
* Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5
* A score of at least 1 for hepatocellular ballooning
Exclusion Criteria:
* Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test
* Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study
* Those persons directly involved in the conduct of the study
* Alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the Lifetime Drinking History questionnaire and the interview version of the Alcohol Use and Disorders Identification Test (AUDIT)
* History of cirrhosis, hepatitis C or other liver diseases
* History of heart failure (New York Association Class II to IV)
* History of taking medications known to cause steatohepatitis
* Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01680003
Study Brief:
Protocol Section:
NCT01680003