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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT04066400
Eligibility Criteria:
Inclusion Criteria:
* histologically proven NASH in the past 36 months with increased ALT: males: \>60, females: \>42 U/ml
* no body weight modification about \>10% in the past 24 weeks
* no new drugs treating parts of the metabolic syndrome in the past 12 weeks
* for patients with Diabetes: HbA1c value \<8,6%
* the ability to understand the aim and the possible individual consequences of this Trial
* signed and dated consent before the Trial starts
Exclusion Criteria:
* unstable coronary heart disease, stroke in the past 6 months
* different liver diseases
* proceeded fibrosis (Fibroscan \>9,6 kPA) or histological cirrhosis
* hepatocellular carcinoma or not curative treated carcinomas
* alcohol consumption \>10g/day (females), \>20g/day (males)
* gravidity
* drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)
* immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)
* warfarin therapy
* implementation of another Special diet
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04066400
Study Brief:
Protocol Section:
NCT04066400