Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02991612
Other study ID # ZS-CSY-RFXM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2016
Est. completion date February 28, 2018

Study information

Verified date May 2018
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date February 28, 2018
Est. primary completion date December 22, 2017
Accepts healthy volunteers No
Gender All
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 tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);

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

- Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.

- Acute variceal bleeding within 5 days.

- Refuse to participate

Study Design


Intervention

Drug:
Rifaximin
Patients receive Rifaximin 400mg bid for 2 months

Locations

Country Name City State
China 180 Fenglin Road Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of all clinical adverse events The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks 8 weeks
Secondary Changes of portal vein thrombosis complete or partial recanalization of thrombosis 2 months
Secondary Changes of intestinal flora Metagenomics sequencing 2 months
Secondary The changes of serum level of cytokines Cytokines including TNF-a, IL-1ß, IL-2R, IL-6 and IL-10, etc 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05014594 - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT Phase 2
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT04939350 - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed NCT02528760 - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis N/A
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Not yet recruiting NCT05538546 - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting NCT02983968 - Use of the French Healthcare Insurance Database
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics Phase 3
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Completed NCT02016196 - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS Phase 3
Withdrawn NCT01956864 - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer Phase 1
Completed NCT01447537 - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01231828 - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. N/A