Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding

Cirrhosis Clinical Trial

— EoR-GEVB  

Official title:

Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Hemorrhage: A Multi-center Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02964195
• Other study ID #: CSY-Rifaximin-HXQ
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 10, 2016
• Start date: November 2016
• Est. completion date: April 2018

Study information

• Verified date: November 2016
• Source: Shanghai Zhongshan Hospital
• Contact: Xiaoquan HUANG, M.D.
• Phone: 18801733835
• Email: huangxiaoquan1010[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Description:

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.

The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 y.o. =age=75 y.o.;

• Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N-butyl-cyanoacrylate injection).

Exclusion Criteria:

• age <18 y.o. or age > 75 y.o.;

• Never had the variceal bleeding episode before;

• Do not have endoscopic treatment;

• combined with other malignant tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment);

• Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)

• Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics.

• Acute variceal bleeding within 5 days.

• Use of other antibiotics in the past 2 weeks;

• Refuse to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cirrhosis
• Esophageal and Gastric Varices
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Drug:
• Rifaximin
ALFA WASSERMANN S.p.A.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Beijing Ditan Hospital, Renmin Hospital of Wuhan University, Shandong Provincial Hospital, The First Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Lanzhou, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases.; Practice Parameters Committee of the American College of Gastroenterology.. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. Erratum in: Hepatology. 2007 Dec;46(6):2052. — View Citation

Gasbarrini A, Corazza GR, Gasbarrini G, Montalto M, Di Stefano M, Basilisco G, Parodi A, Usai-Satta P, Vernia P, Anania C, Astegiano M, Barbara G, Benini L, Bonazzi P, Capurso G, Certo M, Colecchia A, Cuoco L, Di Sario A, Festi D, Lauritano C, Miceli E, Nardone G, Perri F, Portincasa P, Risicato R, Sorge M, Tursi A; 1st Rome H2-Breath Testing Consensus Conference Working Group.. Methodology and indications of H2-breath testing in gastrointestinal diseases: the Rome Consensus Conference. Aliment Pharmacol Ther. 2009 Mar 30;29 Suppl 1:1-49. doi: 10.1111/j.1365-2036.2009.03951.x. Erratum in: Aliment Pharmacol Ther. 2010 Jan;31(1):166. Satta PU [corrected to Usai-Satta P]. — View Citation

Hwang JH, Shergill AK, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Early DS, Evans JA, Fanelli RD, Fisher DA, Foley KQ, Fonkalsrud L, Jue T, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Cash BD; American Society for Gastrointestinal Endoscopy.. The role of endoscopy in the management of variceal hemorrhage. Gastrointest Endosc. 2014 Aug;80(2):221-7. doi: 10.1016/j.gie.2013.07.023. Review. — View Citation

Vlachogiannakos J, Viazis N, Vasianopoulou P, Vafiadis I, Karamanolis DG, Ladas SD. Long-term administration of rifaximin improves the prognosis of patients with decompensated alcoholic cirrhosis. J Gastroenterol Hepatol. 2013 Mar;28(3):450-5. doi: 10.1111/jgh.12070. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All clinical events	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death.	8 weeks	No
Secondary	All clinical events	All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death.	6 months	No
Secondary	Serum endotoxin,		8 weeks, and 6 months	No
Secondary	coagulation function		8 weeks, and 6 months	No
Secondary	inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta		8 weeks, and 6 months	No
Secondary	Glucose breath hydrogen test		8 weeks, and 6 months	No
Secondary	changes of intestinal flora		8 weeks, and 6 months	No