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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT07273734
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80 years.
* Confirmed cirrhosis (biopsy, elastography, or standard radiologic/biochemical criteria).
* Elective TIPS for (a) refractory/recurrent ascites and/or (b) recurrent variceal bleeding not responsive to treatment with endoscopic band ligation and beta-blockers.
* Preemptive TIPS for patients with variceal bleeding and Child-Pugh C (10-13 points), patients with Child-Pugh B and active bleeding during endoscopy, or patients with hepatic venous pressure gradient (HVPG) ≥ 20 mmHg.
* Ability to start study drug within 72 hours before TIPS.
* Signed informed consent.
Exclusion Criteria:
* Contraindications to TIPS (e.g., severe heart failure ≥NYHA III, severe pulmonary hypertension, uncontrolled sepsis, advanced HCC at risk with TIPS, unrelieved biliary obstruction, Child-Pugh score \>13, main-trunk PVT if not recanalizable, technical infeasibility).
* Prior OHE grade II-IV without precipitating factor; overt neurological disease affecting cognition (e.g., Parkinson's, Alzheimer's).
* Current or planned ursodeoxycholic acid (UDCA) therapy for an approved indication (e.g., primary biliary cholangitis), or UDCA use within the prior 3 months.
* Current/recent rifaximin use (\<3 months) or strong UDCA contraindication/hypersensitivity.
* Salvage TIPS.
* Non-cirrhotic portal hypertension.
* Pregnancy/lactation.
* Any condition that, in investigators' judgment, precludes safe participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07273734
Study Brief:
Protocol Section:
NCT07273734