ClinicalTrials.Veeva

Menu

Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding (EoR-GEVB)

Fudan University logo

Fudan University

Status

Unknown

Conditions

Cirrhosis
Gastrointestinal Hemorrhage
Esophageal and Gastric Varices

Treatments

Drug: Rifaximin

Study type

Interventional

Funder types

Other

Identifiers

NCT02964195
CSY-Rifaximin-HXQ

Details and patient eligibility

About

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

Full 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.

Enrollment

308 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

308 participants in 2 patient groups

Rifaximin Group
Experimental group
Description:
Rifaximin 400 mg bid for 2 month,
Treatment:
Drug: Rifaximin
Control
No Intervention group
Description:
Routine endoscopic treatment without prophylactic use of antibiotics

Trial contacts and locations

1

Loading...

Central trial contact

Xiaoquan HUANG, M.D.; Shiyao CHEN, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems