Hepatitis B Clinical Trial
Official title:
The Efficacy and Safety of Rifaximin In The Treatment of HBV Associated Acute-on-Chronic Liver Failure Patients With Mild to Moderate Hepatic Encephalopathy
There will be 124 patients diagnosed as hepatitis B associated acute on chronic liver failure with mild to moderate hepatic encephalopathy will be enrolled in this study according to the inclusion and exclusion criteria, and will be randomly divided into two groups as 1:1.First group is called Rifaximin group, on the basis of comprehensive treatment of liver failure, Rifaximin (Alfa Sigma S.p.A) is added, three times a day, 400 mg each time, for a total of 4 weeks, and observed until 12 weeks after withdrawal. The other group is called standard treatment group (control group), which will receive routine comprehensive treatment for liver failure. The reversal of mild to moderate hepatic encephalopathy in the two groups of patients will be observed within 4 weeks, then follow up to 12 weeks.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | October 31, 2025 |
Est. primary completion date | July 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 1. Inclusion Criteria: - The confirmed HBsAg positive patients with chronic hepatitis B are defined as HBsAg positive for at least 6 months or evidence of chronic HBV infection; - Acute onset, progressive deepening of jaundice, serum total bilirubin (TB) = 85umol/L and severe coagulation dysfunction, international standardized ratio (INR) = 1.5 or plasma prothrombin activity (PTA)<40% - The score of the psychological test scale of hepatic encephalopathy is less than - 4 points or mild to moderate (degree I or II) manifestations of hepatic encephalopathy, including the decline of computational ability, timing and orientation, personality change, lethargy, and positive flapping wing tremor. - Be able and willing to provide informed consent and comply with the test requirements. 2. Exclusion Criteria: - There are definite infections or hepatorenal syndromes during screening; - Upper gastrointestinal bleeding occurred within 1 week before screening; - Have used sedative drugs such as "benzodiazepines" or other psychotropic drugs within one week before screening; - Those with severe primary heart, lung, kidney and other important organ dysfunction affecting life expectancy; - HIV infection; - Uncontrolled malignant tumor, nerve and mental abnormality; - Patients who are allergic to the study drugs and excipients; - Pregnant or lactating women; - In the late stage of liver failure, MELD score>35; - Other circumstances in which the researcher believes that the patient should not participate in this study. |
Country | Name | City | State |
---|---|---|---|
China | The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Bajaj JS, Khoruts A. Microbiota changes and intestinal microbiota transplantation in liver diseases and cirrhosis. J Hepatol. 2020 May;72(5):1003-1027. doi: 10.1016/j.jhep.2020.01.017. Epub 2020 Jan 28. — View Citation
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 — View Citation
Caraceni P, Vargas V, Sola E, Alessandria C, de Wit K, Trebicka J, Angeli P, Mookerjee RP, Durand F, Pose E, Krag A, Bajaj JS, Beuers U, Gines P; Liverhope Consortium. The Use of Rifaximin in Patients With Cirrhosis. Hepatology. 2021 Sep;74(3):1660-1673. — View Citation
Dever JB, Sheikh MY. Review article: spontaneous bacterial peritonitis--bacteriology, diagnosis, treatment, risk factors and prevention. Aliment Pharmacol Ther. 2015 Jun;41(11):1116-31. doi: 10.1111/apt.13172. Epub 2015 Mar 26. — View Citation
Elfert A, Abo Ali L, Soliman S, Ibrahim S, Abd-Elsalam S. Randomized-controlled trial of rifaximin versus norfloxacin for secondary prophylaxis of spontaneous bacterial peritonitis. Eur J Gastroenterol Hepatol. 2016 Dec;28(12):1450-1454. doi: 10.1097/MEG. — View Citation
Goel A, Rahim U, Nguyen LH, Stave C, Nguyen MH. Systematic review with meta-analysis: rifaximin for the prophylaxis of spontaneous bacterial peritonitis. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1029-1036. doi: 10.1111/apt.14361. Epub 2017 Oct 9. — View Citation
Ibrahim ES, Alsebaey A, Zaghla H, Moawad Abdelmageed S, Gameel K, Abdelsameea E. Long-term rifaximin therapy as a primary prevention of hepatorenal syndrome. Eur J Gastroenterol Hepatol. 2017 Nov;29(11):1247-1250. doi: 10.1097/MEG.0000000000000967. — View Citation
Jiang ZD, Ke S, Palazzini E, Riopel L, Dupont H. In vitro activity and fecal concentration of rifaximin after oral administration. Antimicrob Agents Chemother. 2000 Aug;44(8):2205-6. doi: 10.1128/AAC.44.8.2205-2206.2000. — View Citation
Jimenez C, Ventura-Cots M, Sala M, Calafat M, Garcia-Retortillo M, Cirera I, Canete N, Soriano G, Poca M, Simon-Talero M, Altamirano J, Lucey M, Garcia-Tsao G, Brown RS Jr, Schwabe RF, Verna EC, Schnabl B, Bosques-Padilla F, Mathurin P, Caballeria J, Louv — View Citation
Lv XY, Ding HG, Zheng JF, Fan CL, Li L. Rifaximin improves survival in cirrhotic patients with refractory ascites: A real-world study. World J Gastroenterol. 2020 Jan 14;26(2):199-218. doi: 10.3748/wjg.v26.i2.199. — View Citation
Piano S, Fasolato S, Salinas F, Romano A, Tonon M, Morando F, Cavallin M, Gola E, Sticca A, Loregian A, Palu G, Zanus G, Senzolo M, Burra P, Cillo U, Angeli P. The empirical antibiotic treatment of nosocomial spontaneous bacterial peritonitis: Results of — View Citation
Sarin SK, Choudhury A, Sharma MK, Maiwall R, Al Mahtab M, Rahman S, Saigal S, Saraf N, Soin AS, Devarbhavi H, Kim DJ, Dhiman RK, Duseja A, Taneja S, Eapen CE, Goel A, Ning Q, Chen T, Ma K, Duan Z, Yu C, Treeprasertsuk S, Hamid SS, Butt AS, Jafri W, Shukla — View Citation
Sidhu SS, Goyal O, Mishra BP, Sood A, Chhina RS, Soni RK. Rifaximin improves psychometric performance and health-related quality of life in patients with minimal hepatic encephalopathy (the RIME Trial). Am J Gastroenterol. 2011 Feb;106(2):307-16. doi: 10. — View Citation
Wang K, Zhang Z, Mo ZS, Yang XH, Lin BL, Peng L, Xu Y, Lei CY, Zhuang XD, Lu L, Yang RF, Chen T, Gao ZL. Gut microbiota as prognosis markers for patients with HBV-related acute-on-chronic liver failure. Gut Microbes. 2021 Jan-Dec;13(1):1-15. doi: 10.1080/ — View Citation
Wiest R, Lawson M, Geuking M. Pathological bacterial translocation in liver cirrhosis. J Hepatol. 2014 Jan;60(1):197-209. doi: 10.1016/j.jhep.2013.07.044. Epub 2013 Aug 28. No abstract available. — View Citation
Wong F, Piano S, Singh V, Bartoletti M, Maiwall R, Alessandria C, Fernandez J, Soares EC, Kim DJ, Kim SE, Marino M, Vorobioff J, Barea RCR, Merli M, Elkrief L, Vargas V, Krag A, Singh SP, Lesmana LA, Toledo C, Marciano S, Verhelst X, Intagliata N, Rabinow — View Citation
Zeng X, Sheng X, Wang PQ, Xin HG, Guo YB, Lin Y, Zhong JW, He CZ, Yin J, Liu TT, Ma WJ, Xiao X, Shi PM, Yuan ZL, Yang L, Ma X, Xu JM, Shen XZ, Yang CQ, Zhu X, Lv NH, Xie WF. Low-dose rifaximin prevents complications and improves survival in patients with — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The reversal rate of hepatic encephalopathy between 2 groups in 4 weeks. | The reversal rate of hepatic encephalopathy in the 2 groups within 4 weeks will be recorded. | 4 weeks | |
Secondary | The incidence of complications related to liver failure within 12 weeks between 2 groups. | The incidence of complications related to liver failure will be recorded in the 2 groups during 12 weeks. | 12 weeks | |
Secondary | The survival rate between 2 groups within 12 weeks. | The survival rate will be observed in the two groups within 12 weeks. | 12 weeks |
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