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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT00999167
Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 18 and over
* Clinical diagnosis of cirrhosis of any cause
* Potential to benefit from HE treatment
* History of greater than or equal to 2 documented episodes of WH Grade 2 or more HE within the past 6 months, at least one of which occurred within the preceding 3 months
* No change in other HE-specific medications within 1 week before randomization
* Able to give informed consent and comply with study activities
* Availability of at least one designated family member or caregiver who is capable of and willing to assume responsibility for facilitating subject compliance with study procedures
* All females of childbearing age and all sexually active males must agree to use an acceptable method of contraception throughout the study.
Exclusion Criteria:
* Use of any investigational drug within 30 days
* Use of prohibited medications
* Uncontrolled infection
* Active GI bleeding or a history of GI bleeding requiring blood transfusion (\> 2 units) within 3 months
* Transjugular intrahepatic portosystemic shunt (TIPS) placement or revision within the past 90 days
* Recreational drug use or alcohol consumption for subjects with a history of alcohol or drug abuse within 6 months
* Lactating and/or pregnant females
* Active malignancy
* Clinically significant bowel disease, including obstruction, inflammatory bowel disease, or malabsorption
* Expected to undergo transplantation within 6 months
* Model for end-stage liver disease (MELD) score of \> 25
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00999167
Study Brief:
Protocol Section:
NCT00999167