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Completed
NCT07791940
Effect of Rifaximin on Thrombocytopenia in Patients With HCV-Related Liver Cirrhosis
Conditions: Thrombocytopenia Related to Chronic Liver Disease
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 165
Sponsor: Fayoum University Hospital
Location: Faculty of Medicine, Fayoum University Hospital Al Fayyum
Summary
Cirrhosis is a common complication of chronic hepatitis C virus (HCV) infection in Egypt. Thrombocytopenia (TP) is the most common cytopenia in patients with cirrhosis and may be associated with variceal bleeding, rebleeding, morbidity, and mortality. Although TP has traditionally been attributed to portal hypertension and splenic sequestration, other mechanisms include impaired thrombopoietin activity, bone marrow suppression, and increased platelet destruction.
Rifaximin is a poorly absorbed, broad-spectrum intestinal antimicrobial agent widely used in patients with cirrhosis, particularly for hepatic encephalopathy. Its minimal systemic absorption limits systemic adverse effects. Rifaximin may reduce intestinal bacterial overgrowth and bacterial translocation, thereby decreasing circulating endotoxin and proinflammatory cytokines that may contribute to haematological abnormalities in cirrhosis.
Previous observations have suggested that intestinal decontamination with rifaximin may increase platelet counts in patients with cirrhosis and thrombocytopenia. This randomised controlled trial was designed to investigate whether rifaximin treatment could improve platelet count in patients with HCV-related liver cirrhosis and thrombocytopenia.
Eligibility Criteria
Inclusion Criteria: - Patients ages 18-75 years with HCV-related liver cirrhosis with SVR and thrombocytopenia.
The diagnosis of liver cirrhosis was based on a combination of clinical findings (e.g., splenomegaly, ascites, and/or oesophageal varices), laboratory investigations, and imaging studies, including abdominal ultrasonography, computed tomography, or magnetic resonance imaging. Histological confirmation by liver biopsy was available in selected cases.
Exclusion Criteria:
* 1\) Evidence of bacterial infections in the body by:-
* Clinical history
* Physical examination
* Laboratory investigations:
* WBCs (total and differential count)
* CRP.
* Urine analysis.
* Chest X-ray.
* Ascitic fluid analysis (WBCs \& culture and sensitivity) 2) History of variceal bleeding within the 2 weeks preceding this study. 3) Treatment with an antibiotic (including rifaximin) or agents which could have modified the inflammatory process or cytokines (pentoxifylline, steroidal or non-steroidal anti-inflammatory or immunosuppressive drugs) during the last 8 weeks before inclusion.
4\) Evidence of neoplasia, including hepatocellular carcinoma (HCC). 5) History of red cell or plasma transfusion in the month prior to inclusion in this study.
6\) History of significant cardiac, pulmonary, renal, or metabolic comorbidities.
7\) overt hepatic encephalopathy. 8) Active alcohol consumption within the preceding six months. 9) Rifaximin hypersensitivity, 10) Active viral hepatitis requiring direct-acting antiviral therapy 11) Pregnancy or breastfeeding and HIV infection.
Source: ClinicalTrials.gov (NCT07791940). StuddyBuddy aggregates publicly available trial information.