RIFAXIMIN for Alcoholic liver cirrhosis

Inclusion criteria

• {"criterion_text":"- Elective TIPS placement for refractory ascites or recurrent variceal bleeding: • Recurrent tense ascites and one or more of the following criteria: i. Not responding to the maximal dose of diuretics (400mg spironolactone and 160mg furosemide). ii. Kidney insufficiency (Creatinine > 135 umol/L) induced by diuretics. iii. Electrolyte disturbances (Sodium < 125 mmol/L, Potassium > 5.5 mmol/L) induced by diuretics. iv. Not tolerating higher dose of diuretics (e.g. because of subjective side effects like muscle cramps). • (Recurrent) variceal bleeding, not responsive to treatment with endoscopic band ligation and/or beta-blockers, with a high risk of failure of endoscopic treatment: i. Patients with a variceal bleeding and Child-Pugh C (10-13 points) cirrhosis or ii. Patients with a variceal bleeding, Child-Pugh B and an active bleeding during endoscopy\n- Age ≥18 years\n- Confirmed liver cirrhosis as documented by liver biopsy, elastography (e.g. Fibroscan) or combination of usual radiological and biochemical criteria.\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Any absolute contraindications for TIPS placement: a. History of hepatic encephalopathy grade II-IV without precipitating factor b. Heart failure NYHA ≥ grade 3 c. Hepatocellular carcinoma (multifocal or large or centrally located) d. Systemic infection / sepsis e. Severe pulmonary hypertension NL 68205.018.18 / The PEARL trial Version number: 1.9.1, 23 January 2024 21 of 58 f. Unrelieved bile duct obstruction g. Technically not feasible h. Poor liver function (MELD score > 20)\n- Patients refusing or unable to sign informed consent\n- Use of ciclosporin\n- Life-threatening variceal bleeding with emergency TIPS placement which can not be delayed 72 hours\n- Age > 80 years\n- Non-cirrhotic portal hypertension\n- Portal vein thrombosis (main trunk)\n- Current or recent (<3 months) use of rifaximin\n- Overt neurologic diseases such as Alzheimer’s disease, Parkinson’s disease\n- Pregnant or breastfeeding women"}

Primary endpoints

• {"endpoint_text":"- Primary endpoint is the development of OHE within three months after TIPS placement determined by the West Haven criteria.","definition_or_measurement_approach":"Development of OHE within three months after TIPS placement determined by the West Haven criteria."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints include 90-day mortality; development of a second episode of OHE within the first three months; development of OHE in the period between three and twelve months after TIPS placement; development of MHE between TIPS placement and twelve months post-placement; time to development of OHE or MHE episodes; the increase in PHES, S-ANT1 score and LFI compared to baseline.","definition_or_measurement_approach":"Includes 90-day mortality; incidence and timing of OHE and MHE episodes up to 12 months post-TIPS; time-to-event analyses for OHE/MHE; changes from baseline in PHES, S-ANT1 score and Liver Frailty Index (LFI)."}

Belgium

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

06-11-2024

Processing Time Days

28

Number Of Sites

2

Number Of Participants

25

Netherlands

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

04-11-2024

Processing Time Days

26

Number Of Sites

8

Number Of Participants

66

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands