Role of rifaximin in decreasing the circulating levels of endotoxin in patients with cirrhosis

Phase 1

• Conditions: PATIENTS WITH CIRRHOSIS CHILD PUGH B or C Classes; MedDRA version: 20.0Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-000488-34-IT
• Lead Sponsor: MBERTO I - POLICLINICO DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion criteria will be: (i) patients aged 18–75 years; (ii) those with decompensated liver cirrhosis, as confirmed by clinical symptoms and signs, laboratory results, ultrasound and spiral computed tomography (CT) (Child–Pugh grade B or C).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Exclusion criteria will be: i) presence of overt infection or sepsis; ii) treatment with systemic or non-absorbable antibiotic, aspirin or other non-steroidal anti-inflammatory drugs, antidepressant drugs in the previous 30 days; iii) recent need of transfusion of platelets or plasma; iv) presence of extra-hepatic malignancy; v) active alcohol intake in the last 6 months; vi) pregnancy or breast feeding; (v) presence of overt HE, GI haemorrhage, SBP or other concurrent infections during the previous one month; (v) human immunodeficiency virus (HIV) infection; (vi) chronic renal and/or respiratory insufficiency, severe heart disease; (vii) allergy to rifaximin.active post-viral hepatitis requiring or on direct-acting antiviral (DAA) agents; (ix) previous or active intestinal obstruction.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO ASSESS THE EFFECT OF A SHORT-TERM (14 DAYS) TREATMENT WITH RIFAXIMIN (1100 MG/DIE) ON SYSTEMIC LEVELS OF INTESTINAL ENDOTOXIN AND ON PLATELET AND COAGULATION MARKERS IN PATIENTS WITH DECOMPENSATED CIRRHOSIS;Secondary Objective: Not planned;Primary end point(s): Significant decrease (-20%) in serum bacterial LPS (endotoxemia) after 14-day treatment with Rifaximin 550 mg b.i.d respect to the control group as well as after 30 and 60 days from the end of the treatment.;Timepoint(s) of evaluation of this end point: at the end of the treatment as well as after 30 and 60 days after drug discontinuation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Significant correlation between change in serum LPS and thrombin generation and/or platelet activation indexes in both group to support the role of LPS as trigger of clotting activation and platelet activation.; Number of participants with adverse events as a measure of safety and tolerability; Proportion of patients with clinical failure [acute on chronic liver failure: specific syndrome characterized by acute decompensation, organ failure, and high short-term mortality].;Timepoint(s) of evaluation of this end point: a fine trattamento e dopo 30 e 60 giorni dall¿interruzione ; During the interventional period.; at the end of the treatment as well as after 30 and 60 days after drug discontinuation.