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 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT04816916
Eligibility Criteria:
Inclusion Criteria:
* Willing to participate in the study and provide written informed consent.
* Male and female adults aged ≥18 years.
* History of cirrhosis and at least 1 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.
* A PHES of ≤ -4 during Screening.
* MELD score of ≤ 22 at Screening.
* Support of a primary caregiver who is able and willing to give written informed consent.
Exclusion Criteria:
* Hospitalization or serious medical condition.
* Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).
* History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.
* Expectation of a liver transplant during the study.
* Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04816916
Study Brief:
Protocol Section:
NCT04816916