drugset / Trial / NCT06630572
Rifaximin in Cirrhosis: Effects on Endotoxin and Haemostatic Indexes
Phase 4
Terminated
20 enrolled
University of Roma La Sapienza
Azienda Policlinico Umberto I · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Rifaximin is an antibiotic that acts locally in the gastrointestinal tract with a broad spectrum of antibacterial activity. The efficacy of rifaximin is well documented in the prevention of acute hepatic encephalopathy. There is no evidence on its benefit to modulate hypercoagulative state in cirrhotic patient. To assess the effect of a short-term treatment with rifaximin on systemic levels of intestinal endotoxin and on platelet and coagulation markers in patients with decompensated cirrhosis the study has been planned.
Timeline
- Start
- 2021-04-03
- Primary completion
- 2022-04-03
- Completion
- 2024-08-01
Publications
- Background Violi F, Ferro D. Clotting activation and hyperfibrinolysis in cirrhosis: implication for bleeding and thrombosis. Semin Thromb Hemost. 2013 Jun;39(4):426-33. doi: 10.1055/s-0033-1334144. Epub 2013 Mar 13.
- Background Violi F, Ferro D, Basili S, Lionetti R, Rossi E, Merli M, Riggio O, Bezzi M, Capocaccia L. Ongoing prothrombotic state in the portal circulation of cirrhotic patients. Thromb Haemost. 1997 Jan;77(1):44-7.
- Background Nolan JP. The role of intestinal endotoxin in liver injury: a long and evolving history. Hepatology. 2010 Nov;52(5):1829-35. doi: 10.1002/hep.23917.
- Background Raparelli V, Basili S, Carnevale R, Napoleone L, Del Ben M, Nocella C, Bartimoccia S, Lucidi C, Talerico G, Riggio O, Violi F. Low-grade endotoxemia and platelet activation in cirrhosis. Hepatology. 2017 Feb;65(2):571-581. doi: 10.1002/hep.28853. Epub 2016 Nov 5.
- Background Violi F, Basili S, Raparelli V, Chowdary P, Gatt A, Burroughs AK. Patients with liver cirrhosis suffer from primary haemostatic defects? Fact or fiction? J Hepatol. 2011 Dec;55(6):1415-27. doi: 10.1016/j.jhep.2011.06.008. Epub 2011 Jun 28.
- Background Ferro D, Angelico F, Caldwell SH, Violi F. Bleeding and thrombosis in cirrhotic patients: what really matters? Dig Liver Dis. 2012 Apr;44(4):275-9. doi: 10.1016/j.dld.2011.10.016. Epub 2011 Nov 25.
- Background Bass NM, Mullen KD, Sanyal A, Poordad F, Neff G, Leevy CB, Sigal S, Sheikh MY, Beavers K, Frederick T, Teperman L, Hillebrand D, Huang S, Merchant K, Shaw A, Bortey E, Forbes WP. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010 Mar 25;362(12):1071-81. doi: 10.1056/NEJMoa0907893.
- Background Rivkin A, Gim S. Rifaximin: new therapeutic indication and future directions. Clin Ther. 2011 Jul;33(7):812-27. doi: 10.1016/j.clinthera.2011.06.007. Epub 2011 Jul 7.
- Background Danulescu RM, Ciobica A, Stanciu C, Trifan A. The role of rifaximine in the prevention of the spontaneous bacterial peritonitis. Rev Med Chir Soc Med Nat Iasi. 2013 Apr-Jun;117(2):315-20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rifaximin | Other / unclassified | 550 mg | — |