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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT03855956
Eligibility Criteria:
Inclusion Criteria:
* Be able and willing to provide written informed consent
* Be male or female, 18 to 70 years of age (inclusive)
* Have a body mass index (BMI) ≥ 20.0 and \< 40.0 kg/m2
* Well-compensated cirrhosis
* Negative for hepatocellular carcinoma (HCC)
* Adequate safety laboratory values at Screening.
* Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine
* If of child bearing potential must follow contraceptive requirements of the protocol
* Have reliable internet access
Exclusion Criteria:
* Have evidence of decompensated liver disease.
* History or active GI disease.
* Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.
* Subject has a history of drug and/or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03855956
Study Brief:
Protocol Section:
NCT03855956